Establishment of Standard Operating Procedure (SOP)

 

1.0   Purpose

1.1     To provide guidelines for preparation, review, approval, distribution and maintenance of the Standard Operating Procedure so as to lay down clear and concise procedures for effective implementation of quality system as per cGMP.

 

 2.0    Scope

2.1     Applies to all Standard Operating Procedures (SOPs) of ( Name) Pharmaceuticals Ltd. 

   

 3.0    Responsibility

 3.1     All company employees who write, revise, check and approve SOPs are responsible for adhering to the standardized format and content described in this SOP.

3 2    Quality Assurance is responsible for assuring that all SOPs meet the format and content requirements described in this SOP.
3.3     Head of Quality Assurance, Monitoring the system of compliance.

4.0       Abbreviations and Definitions

 4.1        Standard Operating Procedure (SOP): SOP is defined as written, checked, approved and authorized procedure giving instructions for performing operations not necessarily specific to product or material but of a more general nature.

4.2        QA: Quality Assurance

5.0       Materials and Equipment

5.1        Not appreciable.

6.0       Precaution / Health and Safety Considerations

6.1        Ensure pertinent SOP at the user level & returned previous version immediately.

6.2        Follow the SOP format to prepare any standard operating procedure.

6.3        Provide adequate training to the users before implementation of any SOP during operation.

7.0       Procedure

7.1        Preparation and/or revision of SOP(s) shall be initiated by the respective Department and/or from the internal / external audits or if QA decides the requirements to write or review SOP(s) for certain activities.

7.2        Write SOP with consideration for the individuals for whom they are intended. Keep the directions specific and clear. Avoid using unnecessary details when composing the SOP. Use active verbs for procedural directives such as “prepare”, “mix”, “label”, “store” etc.

7.3       General Considerations

7.3.1      All SOP(s) have to be established in this format.  The format is obtainable in the QA Department in the format “word for windows” by diskette or by server.

7.3.2      Paper size, page setup, font size and style etc.

7.3.2.1   Following format shall be used for paper size, quality and page setup:

 

Paper size:	A4 size [8.27” X 11.69”]
Quality	White Offset
Margins:
	Top	1.0”
	Bottom	1.0”
	Right	1.0”
	Left	1.0”
	Gutter	0”
	Header	0.5”
	Footer	1.0”
Orientation:	Portrait (However landscape orientation may be used for annexure or if required).
Paragraphs	General
	Alignment		Justified
	Outline Level		Body Text
	Spacing
	Spacing After		0 pt
	Spacing Before		0 pt
	Line spacing		Multiple, At: 1.15

 

 7.3.2.2   Font sizes and style       : As follows-

Font                             : Arial

Header and footer of front and subsequent pages

Company Name                                      : 14 Bold and capital

Company Address                                  : 10

Standard Operating Procedure               : 13 Bold and capital

Document No./Revision No./Page No.    : 10

Title                                                          : 11 Bold

Prepared By/Checked By/Approved By     : 10 Bold

Front page

Title                                                      : 11 Bold

All other texts                                        : 10

Following pages

General text                                          : 10 (for table font 8 may be accepted)

First rate title                                         : 12 Bold

Second rate title                                    : 11 Bold

Third / fourth / fifth rate title                    : 10 Bold

7.4       Format Considerations

7.4.1     Header and footer of the front page

The header of the front page shall be established like the header of this SOP bearing logo of Company at the left of the header followed to the right with “NAME of Company.”, “STANDARD OPERATING PROCEDURE”, Document No., Revision No. and Page ‘X’ of ‘Y’ (where ‘X’ is the consecutive page number and ‘Y’ is the total number of pages). For format footer contains SOP Reference No at right side.

7.4.2      SOP Number

Each SOP shall bear an own and identical number in an orderly manner. The unique SOP shall be comprised of 9 characters

 

----   ----   ----   ----   ----   ----   ----   ----   ----  

 1      2      3     4      5      6      7     8      9

 

Character 1 & 2 shall indicate the originating department/area/unit such as

 

General Production       : PR                 

Quality Assurance         : QA

Product Development    : PD

Quality Control              : QC

Engineering                   : EN

Warehouse                    : WH

Administration               : AD

Supply Chain                 : SC

Human Resource          : HR

Distribution                   : DS

Marketing                      : MK

 

Character 3 shall indicate “/”

Character 4, 5 & 6 shall indicate sequential number in 3 digits, starting from “001” to “999”.

Character 7 shall indicate “/”

Character 8 & 9 shall indicate version number, starting from “01” to “99”

 7.4.3      Revision No.

For each SOP Revision No. shall be mentioned. For example, “00, 01”, “02” ….”10” etc.

For a new SOP Revision shall be “00”.

7.4.4      Title

Significant explanation of the subject of the SOP. Title shall be short, specific and accurately reflect the content of the SOP.

7.4.5      Supersedes SOP No. and Date

The No. of the former SOP with effective date is specified. In case of New SOP, “New” shall be registered.

7.4.6      Effective Date

The on which the SOP is valid declared. This date is announced by QA.

7.4.7      Review Date

The date on which the SOP should be reviewed is declared. All SOPs shall be reviewed every three (3) years. SOP may be reviewed before the mentioned date, if required, but in any case it should not exceed the given date. Review of the SOP is to be completed within ± one month from the review date.

7.4.8      Prepared By/Checked By/ Approved By

The SOP’s   for each Department except QA shall be prepared by   respective   Department personnel, checked by the  respective  Department  Manager/ Head /In-Charge , approved  by  Head of Quality Assurance.  QA SOP’s shall be prepared by QA personnel, and checked by Asst. Manager/ Manager, QA , approved by Head of Quality Assurance . 

The final SOP will be approved by signing each page of the document in blue ink by the following individual:

-       Person who prepared the SOP

-       Person who checked the SOP for technical contents.

-       Person who approved the SOP for compliance with site GMP.

 

 7.4.9      Header and footer of the following pages

The header of the following pages shall be same as of front page and the additional section shall be a table that states Title with font Arial bold and size 11. The footer contains Prepared by, Checked by and Approved by name, designation signature and date.

7.4.10    Purpose

Describe the specific reason of the SOP. Why is the procedure written? Why is it being performed?

7.4.11    Scope

Extent of parameter (where and when) the SOP shall be applicable. Indicate when the procedure needs to be performed. Indicate where this procedure applies.

7.4.12    Responsibility

Declare who is responsible to follow the SOP or responsible for performing the operations.

7.4.13    Abbreviations and Definitions

Abbreviations, acronym &/or definitions that are used in the SOP shall be stated here. Definitions shall be specific, which needs explanation and clarification.

7.4.14    Materials and Equipment

What is needed to perform this test. Used materials (for example Raw Materials, Reagents, Buffers, Test Plates etc.) and the required equipment is listed (for example Vessel, Filter, pH Meter, Pipettes etc.) The list should be complete and specific.

7.4.15    Precaution / Health and Safety Considerations

Include in all appropriate SOPs. Include physical safety equipment (Goggles, Face Mask), chemical hazard equipment (Gloves, Masks, and Safety Cabinets), reference to Safety Manuals and Material Safety Data Sheet (MSDS) as well as any critical information to ensure the health and safety of the operator.

7.4.16    Procedure

Each process step shall be described in details; thereby each person with adequate knowledge can operate these procedures. Include drawings and diagrams when needed to clarify the instructions. If appropriate, expand this section to include major headings, which may be helpful in organizing and presenting the procedure.

7.4.17    Reference Documents

List reference documents that directly affect or cite the origin the procedure, relevant SOPs, Protocols, Batch Records, Manuals or other informational sources.

7.4.18    Annexes

This section shall state for any annex to be attached with the SOP (e.g. for a cleaning SOP check sheet should be as annexure). All forms in the annex are approved together with SOP. A change of these forms is a change for the SOP and needs approval.

7.4.19    Revision History

The revision history table indicates the total number of revisions for the SOP with brief description of the reasons for revision, their corresponding effective date to maintain link and traceability between the first and current version.

7.4.20    Training

Provide training structure mentioning the designation of the personnel (S) who shall give the training about the SOP to the concerned personnel (S) for the execution of the SOP and its evaluation.

Any SOP shall be made effectiveness only after completion of required training and effective date shall be filled in respective column. There shall be maximum one-week gap duration between the SOP approval date and its effective date.

7.4.21    Distribution List

The SOP shall be distributed to the concerned persons/departments and QA shall record the designation of all SOP recipients in distribution list with copy no.

7.5         Updating of Issued Version

7.5.1     Revision or updates to SOPs must be made on a “For Information Copy Only/ Uncontrolled Copy” or “Controlled Copy” of the previously issued version of SOP.

7.5.2     The SOP should be annotated with the required revisions.

7.6       Approval and Authorization of SOP

7.6.1     The SOP shall be written by an individual familiar with the task to be described by the procedure.

7.6.2     The SOP shall be checked by the person in-charge for the area where the SOP is applicable or designate.

7.6.3     Head of Quality Assurance shall approve the SOP.

7.7       Storage and Issuance of SOP

7.7.1     Master Copy:

The original copy/ Master copy with signatures should remain with QA in the master SOP file. Master Copies/ Original copies of all the SOPs shall be retained by Quality Assurance Department. All the pages of the “MASTER COPY” shall be stamped as “MASTER COPY seal” on back side.

7.7.2     Controlled Copy:

7.7.2.1  The photocopy of the “Master Copy” should be distributed to the concerned Persons/Departments with stamped the control seal (Indicating “CONTROLLED COPY”, COPY NO. and SIGN. & DATE) in blue ink in middle on the bottom of the entire page with signature of QA personnel, issue date and copy no. as per distribution list.

7.7.2.2  QA should record all recipients in the distribution list and distributed SOPs along with SOP Distribution Records Sheet.

7.7.2.3  The recipient should sign. on the Distribution Records Sheet and return to QA and this Records Sheet should remain with master SOP. The recipient may be a person of Department related.

7.7.2.4  If required, QA should distribute additional copies of SOP in any time and record in Distribution Records Sheet with receiving sign.

7.7.3     For Information Copy / Uncontrolled Copy Only

Copies required for reference use by an individual shall carry a stamp “UNCONTROLLED COPY” in blue ink. This copy is not to be used during actual activity.

7.7.4     Obsolete SOP

When a  SOP undergoes   revision, after  the  issue  of  the  revised  SOP,   all  the   superseded controlled copies shall be withdrawn from the respective  Department by  QA  within ten working days. These superseded SOPs shall be destroyed and the “MASTER COPY” of the superseded SOP shall be stamped as “OBSOLETE” in red ink on the face of all pages of SOP and will be retained by QA for future reference for one year. The record of retrieval & destruction of SOPs shall be maintained by QA as per SOP for Document Control.

7.8       Master list of SOP’s

A master list of all SOP’s  shall be prepared by respective Department, checked by functional Manager/ In-Charge, approved by Head of QA and maintained by QA Department. Master list of SOP’s of all Departments shall be updated.

8.0      Reference Document

8.1       A WHO Guide to Good Manufacturing Practice (GMP) Requirements

            Part-1: Standard Operating Procedures and Master Formula.

 

9.0       Annexure

 9.1        Annexure-I         : “Format for the first page of SOP”

 9.2        Annexure-II        : “Format for the consecutive pages of SOP”

 9.3        Annexure-III       : “SOP distribution & retrieval record”

 9.4        Annexure-IV      : “Master COPY, COTROLLED COPY< UNCONTROLLED COPY & OBSOLETE                                            COPY seal format” 

 9.5         Annexure-V       : “Requisition for Additional Controlled & Uncontrolled Copies of SOP” 

9.6        Annexure-VI      :”Format for Master List of SOP”

 

 

 10.0    Revision History

 

Version No.	Brief Reason for the Revision	Effective Date	Remarks
01.	First Version		-
02.
03.

 

 11.0   Training

11.1      Training is required for Managers and Officers of all departments trained by Head of Quality

 Assurance.