1.0 Purpose
1.1 To lay down the procedure that the required information, data & technology about the product, processing & analysis is transferred & available at side so that quality and integrity are maintained.
2.0 Scope
2.1 This SOP shall be applicable to the new products which are transferred from PD or all other product from
one to another site or from contract giver of "NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Head of PD/ Head of QA & QC/ Production Manager / Unit Head/ Contract Giver are responsible for
carrying out the procedure.
4.0 Abbreviations and Definitions
4.1 SOP= Standard Operating Procedure
4.2 QA= Quality Assurance
4.3 PD= Product Development
4.4 QC= Quality Control
4.5 DGDA= Director of General Drugs Administration
4.6 MFR= Master Formula Record
4.7 TGA= Therapeutic Goods Administration
4.8 GMP= Good Manufacturing Practices
4.9 MI= Manufacturing Instruction
4.10 PI= Packaging Instruction
4.11 Technology Transfer: “A logical procedure that controls the transfer of any process together with its
documentation and professional expertise between development and manufacture or between manufacturing
sites”.
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Not Appreciable
7.0 Procedure
7.1 Ensure the new product proposal is approved by PMD
7.2 Manufacturing license for commercial production or test license for registration batches for the proposed
product shall be obtained from DGDA.
7.3 Technology transfer document shall be received from PD.
7.4 Analytical method transfer shall be carried by using approved protocol given by PD.
7.4.1 Upon completion of analytical method transfer, data shall be compiled; report shall be prepared and sent
to PD for review.
7.4.2 Method transfer shall be accepted if results are meeting the acceptance criteria.
7.4.3 The same method shall be used during the routine testing performed subsequently.
7.5 Technology transfer documents shall include
7.5.1 Analytical Method for API (Active Pharmaceuticals Ingredients inclusive of critical tests like Assay, related
substances and residual solvents).
7.5.2 In-process Analytical Methods
7.5.3 Finished product analytical method inclusive of critical tests like Assay, dissolution, related substances
and dissolution profile.
7.5.4 Master formula record or process instructions.
7.6 Based on the technology transfer documents and analytical method transfer, the following document shall
be prepared and approved;
7.6.1 Product Data Sheet
7.6.2 Batch Manufacturing Record (BMR) & Manufacturing Instruction (MI)
7.6.3 Batch Packaging Record (BPR) & Packaging Instruction (PI)
7.6.4 Product Flow Chart
7.6.5 Validation Protocol
7.6.6 Validation Report
7.6.7 Specification for API, Excipients, In-process and Finished product
7.7 For site variation, the existing method/formula as used in license shall be adopted. Separate technology
transfer is not required in case of site transfer products as same process of manufacturing is adopted on the basis
existing MFR provided by PD (contract manufacturing department), any difficult or deviation observed from the
process, specification shall be handled by coordinating with PD.
7.8 For new products launched at any facility by PD, analytical method transfer shall be routed through a
product specific protocol.
7.9 In- case of any change in approved formula, prior approval from contract giver shall be taken.
7.10 The confirmation batches, registration batches shall be manufactured under the technical guidance of PD
or contract giver as per approved validation protocol or batch manufacturing record.
7.11 In-case of any deviation from approved validation protocol or BMR, deviation control procedure shall be
followed.
8.0 Reference Document
8.1 As per WHO GMP guideline,
9.0 Annexure
9.1 Not Appreciable
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
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02 |
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11.0 Training
11.1 Head of Product Development or his/her nominee shall give the SOP training before effective date.
