2.0 SCOPE:This SOP shall be applicable to the new products which are transferred from R&D or all other product from one site to another site or from contract giver.
3.0 RESPONSIBILITY:R&D Head / Head QA & QC / GM-Production / Unit Head / Contract Giver.
4.0 ACCOUNTABILITY:Head- QA & QC
5.0 PROCEDURE:5.1 Ensure the new product proposal is approved by QA.
5.2 Manufacturing license for commercial production or test licence for registration batches for the proposed product shall be obtained from local FDA.
5.3 Technology transfer documents shall be received from R&D or contract giver.
5.4 Analytical method transfer shall be carried out by using approved protocol given by R&D or contract giver.
5.4.1 Upon completion of analytical method transfer, data shall be compiled; report shall be prepared and sent to R&D or contract giver for review.
5.4.2 Method transfer shall be accepted if results are meeting the acceptance criteria.
5.4.3 The same method shall be used during the routine testing performed subsequently.
5.5 Technology transfer document shall include;
5.5.1 Analytical method for API (Active Pharmaceutical Ingredient(s)) inclusive of critical tests like assay, related substances and residual solvents.
5.5.2 In-process analytical methods.
5.5.3 Finished product analytical method inclusive of critical tests like assay, dissolution, related substances and dissolution profile.
5.5.4 Master formula record or process instructions.
5.6 Based on the technology transfer documents and analytical method transfer, the following documents shall be prepared and approved;
5.6.1 Batch manufacturing record
5.6.2 Validation protocol
5.6.3 Batch packaging record
5.6.4 Specification for API, excipients, in-process and finished product.
5.7 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 of existing MFR provided by R&D (contract manufacturing department), any difficulty or deviation observed from the process, specification shall be handled by coordinating with R&D.
5.8 For new products launched at any facility by R&D, analytical method transfer shall be routed through a product specific protocol.
5.9 In case if any change in approved formula, prior approval from contract giver shall be taken.
5.10 The confirmation batches, registration batches shall be manufactured under the technical guidance of R&D or contract giver as per approved validation protocol or batch manufacturing record.
5.11 Necessary training shall be provided to the concerned people.
5.12 In case of any deviation from the approved protocol or BMR, deviation control procedure shall be followed.
Related: Analytical Method Development
6.0 ABBREVIATIONS:6.1 SOP: Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 R&D: Research and Development
6.5 FDA: Food and Drug Administration
6.6 API: Active Pharmaceutical Ingredient
6.7 MFR: Master Formula Record
6.8 BMR: Batch Manufacturing Record
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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