1.0 Purpose
1.1 To describe a procedure for approving materials from new suppliers / manufacturers for raw or packaging materials and delisted of approved suppliers.
2.0
Scope
2.1 This Sop is applicable for all raw and
packaging materials of NAME Pharmaceuticals Ltd.
3.0
Responsibility
3.1
Procurement department is
responsible for collecting sample and necessary documents from supplier and
send to QA.
3.2
Product Development is
responsible for define specifications and checking suitability of new materials
in Process.
3.3
Quality Control is responsible
for necessary analysis of new source sample.
3.4
Quality Assurance is
responsible for arranging all communications and final approving the source.
4.0 Abbreviations and Definitions
4.1 Manufacturer : A company that carries out at least one step of manufacture.
4.2 INN : International Nonproprietary Name.
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 None
7.0 Procedure
7.1 Establishing the suitability of the source of existing and new material
7.1.1 Whenever it is deemed necessary, procurement Department shall locate new supplier(s) for existing materials as well as new materials.
7.1.2 Product Development shall develop material specification, keeping liaison with Quality Control and based on this. Head of Procurement shall start locating source from Manufacturer or through local agents.
7.1.2.1 For any change in specification of existing material, Quality Control shall inform Procurement Department, keeping liaison with Product Development and Procurement Department inform immediately to Manufacturer Directly or through local agents.
7.1.3 To evaluate a manufacture, Procurement Department shall send a vendor Questionnaire (Annexure-I) Which is to be duly filled up by the supplier and thereafter assessed by Quality Assurance.
7.1.4 The following items are to be considered before sending the Questionnaire to Suppliers
· Manufacturer’s reputation
· Manufacturer’s product specification, brochure must meet our specified requirements
· Local suppliers (Primary /secondary packaging materials) are evaluated to be a potential supplier having manufacturing facility of their own.
7.1.5 Quality Assurance Department shall evaluate the Questionnaire and sample shall be asked from the supplier or further advice to be given for improvement and future consideration (Annexure- II).
7.1.6 For development of any new source for any existing or new raw /packaging material.
Flow Chart - 1 is to be followed.
7.1.7 Procurement Department shall collect the following information from the supplier and send to QA or PD (if applicable)
· Samples of the material from at least one batch (at least 10 gm from each batch) and certificate of analysis for three batches along with Working Standard accompanied by certificate of analysis for both (WS and material)
· A copy of supplier’s specification, Method of analysis or a statement of the compliance with any pharmacopeia (BP and USP) requirements.
· Material safety data sheet (MSDS) and Stability data (in case of raw materials).
7.1.8 The material (Sample) shall be sent to QC and to be analyzed according to the full BP/ USP or as per suppliers’ specification (in case of INN materials) Additional tests are also be considered, if required.
7.1.9 For packaging materials following quantity of materials are required for test and machine trail. Items Required Quantity
Film (PVC & PVC/PVDC) 5.0 kg
Carton / Leaflet or others 500 pcs
7.1.10 Whenever possible suppliers manufacturing facility is to be audited by
7.1.11 Based on the analytical data and available documents .QA shall approve / reject the source provisionally through the form “Disposition of new source / material”. Initial order may be placed for a quality sufficient to manufacture three production batches or a minimum order quantity.
For raw material of a new source, QA reference shall be API/XXX/ YY and for packaging material QA reference shall be EPI/XXX/YY, Where ‘XXX’ is sequential number starting from ‘001’ and ‘YY’ is year, as example 24 for year 2024 .The register shall be maintained by QA.
7.1.12 Copy of the Disposition sheet shall be provided to procurement Department and PD Department (in case of new material).
7.1.13 After satisfactory production of three batches, include the supplier in the Vendor list.
7.1.14 A copy of the updated and approved Vendor list shall be sent to Procurement Department (whenever change in the list is made).
7.1.15 It is recommended that three suppliers /sources are to be developed for a material, but the number should not exceed five. For development of any additional source i.e., more than five. Proper justification is to be provided by Procurement Department to QA with proper approval.
7.2 De-listing of Approved Suppliers
7.2.1 If no consignment is received in two years, then the supplier shall be de-listing. Procurement
Department shall de-list the supplier and a copy of the information shall be sent to QA Department.
7.2.2
Approved suppliers de-listed when they fail to
maintain following criteria.
· Quality
· Price
· Service
7.2.3
The purchase order shall bear the salient
terms and conditions of the company’s purchase protocol in order to make the
suppliers well informed of the de-listed procedure.
7.2.4
Based
on Quality
Foreign Suppliers
7.2.4.1 A
supplier shall be judged inconsistent in maintaining specified quality, Quality
Assurance rejects any consignment. Procurement Department shall then reveal
this complaint to local agent or directly to the supplier for their clarification.
Supplier’s clarification on quality aspects shall be considered acceptable if
they provide sufficient reasons shoeing the cause of non-conformance. For the
first instance of failure, the supplier shall be advised to maintain quality in
future supplies. If clarification is not acceptable, the supplier shall be
cautioned for the first time. In all cases, compensation or replacement for
rejected material shall be realized.
7.2.4.2 If two
consignments are rejected, the supplier shall be suspended until logical
clarification is received. If the supplier’s clarification is not acceptable
for the second time the supplier shall be considered de-listed.
Local Suppliers
7.2.4.3 Unlike
foreign suppliers, inconsistency in maintaining desired quality of supplied
secondary packaging materials shall not lead to de-listing of the supplier. The
supplier shall, however be cautioned to ensure supplying of the quality
products against rejection (if any), but the rate of rejection shall be
monitored. If the frequency of rejection is high and more than five times a
year the supplier shall be more seriously dealt with and possibility of
de-listing shall be considered.
7.2.5
Based
on Price
7.2.5.1 If a
supplier fails to quote competitive price for one calendar year, the supplier
may be de-listed approved supplier list provided more than two suppliers exist
in the list.
7.2.6
Based
on Service
7.2.6.1 A supplier shall be de-listed, if it fails to
satisfy terms of contact twice in a single calendar year for foreign suppliers
while it shall be de-listed if such things occur five times in case of local
suppliers.
7.2.6.2 The
terms include service such as delivery schedule, supplying condition, after
sales service, compensation for damage etc.
8.0 Reference Document
8.1 WHO GMP Guideline; TRS-986, Annex-2 ;
8.2 In house
9.0 Annexure
9.1 Annexure-I : SUPPLIER QUESTIONNAIRE
9.2 Annexure-II : VENDOR QUESTIONNAIRE (BULK PHARMACEUTICAL CHEMICALS)
10.0
Revision
History
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Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
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01 |
New |
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11.0 Training
11.1 Head of Quality Assurance or his nominee give the training of all Officer and Manager of all Department.
Annexure-I
SUPPLIER QUESTIONNAIRE
All page to be completed by Supplier and submitted to
Quality Assurance Department of NAME Pharmaceutical Ltd. through Procurement
Department.
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Questionnaire Issued by NAME |
Received by Supplier |
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Name |
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Designation |
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Date |
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GENERAL |
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1.0
Name, Address, Telephone, fax and
Internet address of the company ………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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2.0
Name of the material /product to be
supplier ………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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3.0
List of Raw Materials / Packaging Materials manufactured
by the company or by affiliates (attach sheet, if required) ………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. Indicate approved raw
materials sources for the company’s major product ………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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Mark
( Ö )
where applicable |
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4.0
Do you manufacture the products you supply? If no, who is the manufacture? ………………………………………………………………………….. |
Yes Š No Š |
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5.0 Do you
repackage material from other manufacturers? |
Yes Š No Š |
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6.0 Approximately
what percentage of your output is for pharmaceuticals customers? |
…………….. % |
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7.0 Have you manufacturing premises been inspected by a
regulatory authority or independent quality certification organization? If yes, please
quote the name of the authority, any license number and date:
………………………………………………………………. …………………………………………………………………………… |
Yes Š No Š |
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MANUFACTURING |
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1.0
As per your system, what is your definition of a lot or
Batch? ………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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2.0
Please give an example of the type of
batch number used to identify each individual batch number of a product ………………………………………………………………………………. |
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3.0
What is a typical batch size? ………………………………………… |
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4.0 Is more than one product manufactured
in the same manufacturing plant
/ facility? |
Yes Š No Š |
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5.0Does batch identity allow for tractability of : |
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a. |
Input materials? |
Yes Š No Š |
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b. |
In-process check? |
Yes Š No Š |
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c. |
Final product testing? |
Yes Š No Š |
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6.0 Are these
records formally evaluated by Quality Assurance? |
Yes Š No Š |
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7.0 Are any
material manufactured at more than one site? ……………………………………………………………………………… ……………………………………………………………………………… |
Yes Š No Š |
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8.0 Are all
personnel aware that materials are for Pharmaceutical use? |
Yes Š No Š |
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9.0 All
product manufactured by following a written procedure? |
Yes Š No Š |
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10.0 Are
written records maintained for each batch giving a complete record of the
manufacturing history? i. e. |
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a. |
Equipment
use? |
Yes Š No Š |
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b. |
Description,
quantity and batch number of raw materials used? |
Yes Š No Š |
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c. |
Date
of Manufacture? |
Yes Š No Š |
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d. |
Results
of in-process controls? |
Yes Š No Š |
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e. |
Records
of any deviation from written procedure? |
Yes Š No Š |
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f. |
Reworks
and re-inspections? |
Yes Š No Š |
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g. |
How long are these records kept? …………………………….. Years / Months |
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11.0 Are
control instruments calibrated regularly? |
Yes Š No Š |
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12.0 Are
rejected materials clearly identified as such? |
Yes Š No Š |
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13.0 Is disposal of rejected materials,
rework of intermediates or finished product
covered by a written procedure? |
Yes Š No Š |
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14.0 Are different grades material i.e.,
pharmaceutical / Technical manufactured
on the same plant? |
Yes Š No Š |
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15.0 Do you
have a training programme for: |
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a. |
Production Personnel? |
Yes Š No Š |
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b. |
Quality Assurance Personnel? |
Yes Š No Š |
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16.0 Are record
kept of any training received by: |
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a. |
Production Personnel? |
Yes Š No Š |
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b. |
Quality Assurance Personnel? |
Yes Š No Š |
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17.0 Is
Production single shift (A) or multiple shift (B)? Š
A / Š B |
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18.0 Is
Quality Assurance single shift (A) or multiple shift (B)? Š A / Š B |
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19.0 Do you
have a formal system of equipment and line clearance? |
Yes Š No Š |
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20.0 Do you
have a yield reconciliation system? |
Yes Š No Š |
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21.0 Do you
retain samples from each batch? If yes,
for how long? …………………………………………………. |
Yes Š No Š |
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22.0 Do
personnel wear clothing appropriate to the job? |
Yes Š No Š |
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23.0 Is their
evidence of effective programme in place to address safety and occupational health and
hygiene matters? |
Yes Š No Š |
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24.0 Are labels
and printed materials stored adequately? |
Yes Š No Š |
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25.0 Is
reconciliation labels satisfactory? |
Yes Š No Š |
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26.0 Provide
list of Qualified persons (with Qualification) directly involved in
manufacturing. |
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27.0 Contract
Manufacture |
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a. |
Do you undertake contract manufacture for other
companies? |
Yes Š No Š |
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b. |
Do you subcontract to other companies? |
Yes Š No Š |
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28.0 Complaints
and Recalls |
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a. |
Do you have a recall procedure? |
Yes Š No Š |
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b. |
Please indicate significant complaints any recalls in
last two years ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. |
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BETA- LACTAMS |
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1.0 |
Do you manufacture penicillin or other Beta-Lactam
antibiotics? |
Yes Š No Š |
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Is yes, does this production take place in a separate
building? |
Yes Š No Š |
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2.0 Is there any Process of de-activating
the penicillin effluent before disposal? |
Yes Š No Š |
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3.0 What is
the level of detection of penicillin at
ppm level? ……………………………………….. |
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RESEARCH AND DEVELOPMENT ACTIVITIES |
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1.0
Please indicate the type of activities
and annual investment in term of USD …………………………………………………………………………………………………………… …………………………………………………………………………………………………………… |
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2.0 Do you
have any facility for stability study? |
Yes Š No Š |
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QUALITY ASSURANCE |
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1.0 Is the
Quality function organized as a separate: |
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a. |
Quality Assurance Department |
Yes Š No Š |
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b. |
Quality Control Department |
Yes Š No Š |
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c. |
If there is no defined quality function, who is
responsible for assuring the materials meets the required specification? …………………………………………………………………………………………………………… …………………………………………………………………………………………………………… |
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2.0 Which
aspects of your operations covered by QA / QC ? |
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a. |
Testing
of incoming materials? |
Yes Š No Š |
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b. |
In-process
controls? |
Yes Š No Š |
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c. |
Final
product testing? |
Yes Š No Š |
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3.0
To whom does the person responsible for
quality report? ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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4.0 Does your
quality function have the responsibility to release or reject each batch of: |
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a. |
Starting
materials? |
Yes Š No Š |
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b. |
Intermediate
Product? |
Yes Š No Š |
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c. |
Finished
Product? |
Yes Š No Š |
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5.0 Provide
list of Qualified persons (with Qualification) directly involved Quality
Assurance. |
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CERTIFICATE OF ANALYSIS |
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1.0 |
Are Certificate of analysis available for the raw
materials supplied? |
Yes Š No Š |
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If no, would you be prepared to negotiate with a view to
supplying a suitable certificate? |
Yes Š No Š |
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2.0 Would the
certificate actually reflect an analysis on the particular batch? |
Yes Š No Š |
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ENVIRONMENT |
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1.0
Do you have an environmental policy? If
yes, will you please supply a copy? |
Yes Š No Š |
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MISCELLANEOUS |
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1.0 Materials
specification / standard: …………………………………………………………….. |
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2.0 Product
specially : ……………………………………………………………. |
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3.0 List of
other materials, if manufactured: Š Enclosed / Š Not enclosed / Š Not available |
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4.0 Safety
Data Sheet : Š available Š Not available Š Already supplied |
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5.0
Reference list of other buyers of the
material (Local & Overseas) : Š Enclosed / Š Not enclosed / Š Not available |
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6.0
a.
Certification of local Drugs Control Authorities: ………………………………………………… b. Certification of
international bodies i.e., FDA, WHO etc. if obtained ………………………………………………………………………………………….. |
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7.0
Date of last inspection by the above
bodies: a) Local : ………………………………. b)
International : ………………………………. |
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8.0 ISO-9000
Certification status and last date of Inspection, if any ………………………………. |
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9.0 Name and
address of Certification authority : ………………………………………………….. |
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10.0 Quantity
of Sample, If provided : …………………………………………………………………….. |
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11.0 Certificate
of analysis : …………………………………………………………………….. |
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12.0 Will you
inform us if changes take place that significantly affect the information
given above? |
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AUTHENTICATION |
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I hereby certify that the information provided above and
in all the annexes is true. |
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Name : |
………………………………………………………………………. |
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Functional Title : |
………………………………………………………………………. |
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Company Name : |
………………………………………………………………………. |
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Signature : |
………………………………………………………………………. |
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Date : |
………………………………………………………………………. |
Annexure-II
(BULK
PHARMACEUTICAL CHEMICALS)
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Name of Vendor Company |
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………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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Address (Corporate Headquarters) |
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………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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Telephone, Telefax and email |
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………………………………………………………………………………………………………………. |
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Address (Manufacturing Site) |
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………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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Telephone, Telefax and email |
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………………………………………………………………………………………………………………. |
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Materials Purchased |
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………………………………………………………………………………………………………………. |
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Materials to be Purchased |
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………………………………………………………………………………………………………………. |
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List of Raw Materials / Packaging
Materials manufactured by the company (Attach sheet, if require) |
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………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. |
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Mark ( Ö )
where applicable |
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1.0 GENERAL INFORMATION |
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1.1 In what year the Company established? |
……………………………………………….. |
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1.2 Who
owners the Company? …………………………………………………………………. ………………………………………………………………………………………………………… |
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1.3 Is there a registered Drug Master File
(DMF) ? If yes,
provide the DMF number and the name of the Regulatory Agency
………………………………………………………………… ……………………………………………………………….…………. |
Yes Š No
Š |
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1.4 Who is
the primary Quality Assurance contract? |
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Name : |
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Job
Title : |
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Phone
No. : |
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E-mail : |
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1.5 |
Are
other products manufactured besides Bulk Pharmaceutical Chemicals |
Yes Š No
Š |
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At
the same Site as the Bulk Pharmaceutical Chemicals? If
yes, specify the other types of products- ………………………………………………………………………..…….. ……………………………………………………………………………… |
Yes Š No
Š |
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1.6 |
Are
any of the following produced at the same Site as materials to be purchased? Antibiotics
(If yes, specify each type ) Types …………………………………………………………………………. |
Yes Š No
Š |
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Cytotoxic |
Yes Š No
Š |
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Steroids |
Yes Š No
Š |
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Pesticides
/ Herbicides |
Yes Š No
Š |
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Biologicals |
Yes Š No
Š |
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Specify :…………………………………………………………………………………………………… …………………………………………………………………………………………………………….. |
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1.7 Have your manufacturing premises been
inspected by a Regulatory Authority
or independent Quality Certification Organization? If yes, quote the name of the
Authority, any License number and date ……………………………………………………………………………… ……………………………………………………………………………… |
Yes Š No Š |
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1.8 |
a) Certification
of Local Drugs Authority:
…………………………………………………….. |
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b) Certification of International Bodies i.e. US-FDA, UK-MHRA,
WHO etc. If obtained ………………………………………………………………………………………… |
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1.9 |
Date of last inspection by the above bodies: a)
Local : ……………………………………………… |
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b)
International : ………………………………………………: |
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1.10 Would you be willing to have your Plant
and Batch Documentation audited
by NAME Pharmaceuticals Personnel’s? |
Yes Š No Š |
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2.0 ORGANIZATION AND PERSONNEL |
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2.1 Attached an Organizational Chart
showing the reporting structure of the
Company. Attached-
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Yes Š No Š |
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2.2 How many Production Employees are in
the Company ? :
………………………….. |
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2.3 How many Quality Assurance Employees
are in the Company ? : ………………………….. |
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2.4 |
Is there a written program for Training? |
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a. |
New
employee? |
Yes Š No Š |
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b. |
Current
employee? |
Yes Š No Š |
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2.5 Are written Training records
maintained for all Employees? |
Yes Š No Š |
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2.6 Who is responsible
for Batch Record Review prior to release? ………………………………………………………………………………………………………….. |
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2.7 Who is
responsible for review and approved of Standard Operating Procedure (SOP)? ………………………………………………………………………………………………………….. |
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2.8 Who is
responsible for review and approved of Master Approved Documents? ………………………………………………………………………………………………………….. |
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2.9 Is there
an SOP for the revision of Master Approved Documents? |
Yes Š No Š |
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2.10 Which
Department approves Product Specifications? ………………………………………………………………………………………………………….. |
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3.0 BUILDINGS
AND FACILITIES |
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3.1 Is there
a written Pest Control program? |
Yes Š No Š |
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3.2 Are records of Pest Control
maintained? |
Yes Š No Š |
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3.3 |
Is
there an SOP for cleaning the Facilities? |
Yes Š No Š |
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Between
Batches of the same Product? |
Yes Š No Š |
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Between
different Products? |
Yes Š No Š |
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3.4 Are records for cleaning maintained? |
Yes Š No Š |
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4.0 EQUIPMENT |
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4.1 Is there
a written Calibration Program for all instrumentation used in Production and Quality Control
equipment? |
Yes Š No Š |
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4.2 Are there
Calibration records for each instrument? |
Yes Š No Š |
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4.3 Is there
a written preventive maintenance program for all equipment’s used in Production? |
Yes Š No Š |
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4.4 Is there
written Cleaning Procedure for each piece of non- dedicated equipment’s? |
Yes Š No Š |
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4.5 |
Is there a written cleaning Validation program? |
Yes Š No Š |
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Briefly describe the validation procedure. …………………………………………………………………………………………………………… …………………………………………………………………………………………………………… …………………………………………………………………………………………………………… ……………………………………………………………………………………………………………. |
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5.0 CONTROL
OF MATERIALS |
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5.1 Is there
a list of approved suppliers of Raw Materials? |
Yes Š No Š |
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5.2 Is there
a FIFO system for stock rotation? |
Yes Š No Š |
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5.3 Are their separate areas defined for
storage of materials receipt and after
testing? |
Yes Š No Š |
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5.4 Are there
Temperature and Relative Humidity Controls in place in the Warehouse? If yes,
specify the limits. …………………………………………………………………………….. |
Yes Š No Š |
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5.5 Briefly describe precautions taken to
prevent contamination of Materials during Dispensing Operation: ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. |
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5.6 Are
Reserve samples of Raw Materials retained? |
Yes Š No Š |
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5.7 Is there
a written sampling plan for all raw materials used in product? |
Yes Š No Š |
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5.8 Are any of the raw materials used in
Products accepted on the basis of
the manufacturer’s Certificate of Analysis only? If yes, how often are these
materials actually tested in the Laboratory? ……………………………………………………………………………….. |
Yes Š No Š |
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6.0 PRODUCTION
AND PROCESS CONTROL |
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6.1 Is there a Process Flow Diagram for
the manufacture of each Product? If yes, attach a copy of those
that are relevant. Attached |
Yes Š No Š |
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6.2 Is there a Process Validation Report
available for all Products? If yes, attach a copy of those
that are relevant. Attached |
Yes Š No Š |
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6.3 Is there an SOP describing how
Deviation from the Master Batch Record
are handled? |
Yes Š No Š |
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6.4 Which
Department is responsible for approving Investigations into such
Discrepancies? ……………………………………………………………………………………………………………… |
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6.5 Which
Department is responsible for handling Complaints? ……………………………………………………………………………………………………………… |
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6.6 Are complaint investigations extended
to other batches of the same product? |
Yes Š No Š |
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6.7 Briefly describe at which stages in
the production process Yield Calculations and materials are made and how. …………………………………………………………………………………………………………….. …………………………………………………………………………………………………………….. …………………………………………………………………………………………………………….. |
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6.8 Is there a procedure limiting the
amount of time allowed between successive
production steps? |
Yes Š No Š |
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6.9 |
Are there procedures for performing Reprocessing? |
Yes Š No Š |
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If yes, attach a copy of your SOP, Attached. |
Yes Š No Š |
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6.0 PRODUCTION
AND PROCESS CONTROL |
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6.10 Are there procedure for performing
recovery of mother Liquors or Solvents? If yes, briefly describe the
procedure. ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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6.11 Describe In-Process controls for
relevant stage of the manufacturing process. ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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6.12 |
Is there an SOP for Change Control to the process or to
equivalent or system |
Yes Š No Š |
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If yes, does it require QA approval prior to making the
change? |
Yes Š No Š |
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6.13 |
Are any parts of the production Process performed by
Subcontractors? (e.g. micronizing) |
Yes Š No Š |
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If yes, give the name and address of any Subcontractors
used and describe what activities they perform. ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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6.14 Is there a
signed agreement (Contract giver / Receiver) with each Subcontractor, delineating
responsibilities covered by cGMP? |
Yes Š No Š |
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6.15 |
Are there procedures for performing Reprocessing? |
Yes Š No Š |
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|
If yes, attach a copy of your SOP, Attached. |
Yes Š No Š |
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6.16 Are
Rejected Materials clearly identified? |
Yes Š No Š |
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|
6.17 Is there
any written procedure for disposal of rejected Materials or Finished Products? |
Yes Š No Š |
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6.18 Do you
have Internal Quality Audit system? |
Yes Š No Š |
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7.0 PACKAGING
AND LABELING CONTROL |
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|
7.1 Are there written procedures for the
receipt and testing of Packing and Labeling
Materials? |
Yes Š No Š |
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|
7.2 Is there written procedures for
issuing printed Packing Materials? |
Yes Š No Š |
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7.3 Briefly describe line clearance
procedures prior to Packing and / or Labeling operations? ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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7.4 Describe the Batch Coding system ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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|
8.0 LABORATORY
CONTROLS |
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|
8.1 How many Employees
are in the Laboratory? ……………………………………………………………………………………………………………… |
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8.2 Is there Laboratory situated at the
same location as the manufacturing site? |
Yes Š No Š |
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|
8.3 To whom
does the Laboratory Manager report? ……………………………………………………………………………………………………………… |
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|
8.4 List the
major Equipment items of the Laboratory (Attached sheet, if required) ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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8.5 Are microbial counts performed on
Finished Products? |
Yes Š No Š |
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|
8.6 Are the written procedure for
Questionable Results? |
Yes Š No Š |
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|
8.7 In the event that a result of a test
does not perform to specifications, when performed for the first time describe what action is
taken. ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… |
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8.8 |
Are
retest performed? |
Yes Š No Š |
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|
On the same sample or on a new sample? ………………………………………………………………………………………………………… |
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|
8.9 |
Are
samples of each batch of each product manufactured returned? |
Yes Š No Š |
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|
If yes, on what is the size of the sample based? ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… |
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|
8.10 |
Is there a written Stability testing program? |
Yes Š No Š |
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|
Briefly outline the program. ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… |
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|
8.11 Is Stability testing performed in the
final Product Container? |
Yes Š No Š |
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|
8.12 Do all products bear Expiration Dates? |
Yes Š No Š |
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|
8.13 |
Are
contract Laboratories used to perform testing? |
Yes Š No Š |
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|
If
yes, is there a written Audit program for such Laboratories? |
Yes Š No Š |
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|
8.14 Attach a copy of a Certificate of
Analysis for one product. Attached: |
Yes Š No Š |
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|
9.0 ENVIRONMENTAL |
||
|
9.1 |
Do
you have an environmental Policy? |
Yes Š No Š |
|
If
yes, will you attach a copy? Attached: |
Yes Š No Š |
|
|
AUTHENTICATION |
|
|
I hereby certify that the information provided above and
in all the annexes is true. |
|
|
Name : |
………………………………………………………………………. |
|
Functional Title : |
………………………………………………………………………. |
|
Company Name : |
………………………………………………………………………. |
|
Signature : |
………………………………………………………………………. |
|
Date : |
………………………………………………………………………. |
