Standard Operating Procedure of Concurrent Process Validation in Pharmceuticals plant is describe in this post.
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1. PURPOSE
1.1 Establish documented evidence that provides a high degree of assurance that the process will constantly produce a product which meets established specifications.
1.2 Ensure that product is produced with minimum wastage & smooth analytical results.
1.3 Fine tune the process so that smooth running of production is guaranteed with minimum Lead-time, manpower & utility consumption.
1.4 Achieve a high quality product at each stage of process, every time.
2. SCOPE
This procedure is applicable,
2.1 For concurrent process validation, when production, testing and other informations for a product already in production and distribution is not sufficient for retrospective process validation.
2.2 For revalidation of concurrently validated process.
3. RESPONSIBILITY
3.1 Concurrent process validation is carried out by Q.A department.
3.2 The Validation team for concurrent process validation comprises of Q.A Manager, Executive Q.A Validation, Production Manager and Q.C Manager.
3.3 Q.A Manager approves the process validation Protocol, Report and any change in the process suggested by the validation team.
3.4 Q.C Manager is responsible to manage the testing of validation samples and to verify all the Q.C results.
4. MATERIAL & EQUIPMENT
4.1 Sampling rod
4.2 Polyethylene bags/ bottles (for Samples)
4.3 Product subjected to validation
5. PROCEDURE
5.1 Concurrent process validation (on Three consecutive batches) is carried out in following cases,
a. Process not already prospectively validated
b. When production, testing and other information for a product already in production and distribution is not sufficient for retrospective process.
5.2 “Quarterly Schedule for Concurrent Process validation” is prepared by Executive Q.A Validation with the consultation of Validation team (on the basis of their production units, therapeutic category).
5.3 Production Manager helps the Executive Q.A Validation in the preparation of process validation protocol and process validation schedule.
5.4 This Schedule is signed by validation team, approved by Q.A Manager and further completed by Executive Q.A Validation.
5.5 Production Pharmacist verifies the processing steps along with Q.A department during the process validation.
5.6 Process validation is carried out as per process validation protocol.
5.7 Process Validation Protocol is approved by Q.A Manager which includes,
5.7.1 Purpose, responsibilities and general description of the process
5.7.2 Process Flow Diagram
5.7.3 Raw & Primary Packaging Materials to be used.
5.7.4 List of Equipments to be used
5.7.5 Critical Process stages and Control variables of each processing stage.
5.7.6 Environmental requirements of each processing stage.
5.7.7 Sampling Plan along with test to be performed and responsibility.
5.7.8 Stepwise Batch Yield / Quantity Comparison.
5.7.9 Hold-Time Study
5.8 Protocol Numbers for Concurrent Process Validation Protocol (CPVP) and Report Numbers for Concurrent Process Validation Report (CPVR) are assigned by Executive Q.A Validation from Process Validation Log Book at the time of approval of protocol.
5.9 To allot Protocol No. and Report No., a uniform numbering System is followed as CCCC/DDD/000
CCCC = Protocol or Report e.g. CPVP (Concurrent Process Validation Protocol)
or
CPVR (Concurrent Process Validation Report).
DDD = Product Code
000 = Serial Number.
5.10 Serial Number of Report no. is same as its serial # in Protocol No.
5.11 Process validation protocol and Process Validation Report are filled by Executive Q.A Validation with the help of validation team.
5.12 Executive Q.A Validation/ Q.A Officer performs process monitoring, parameter recording, physical testing (Optional) and validation sampling.
5.13 Executive Q.A Validation/ Q.A Officer collects the validation samples as per sampling plan given in the protocol and sends to Quality Control Department for testing.
5.14 Validation samples are not used for product release and are separate from those taken by Q.A for Q.C testing.
5.15 HOLD-TIME STUDY:
5.15.1 Hold-time study is performed only on one validation batch.
5.15.2 Stages to be sampled for Hold-Time Study of each product type are given in the protocol.
5.15.3 Store the samples up to 60 days or more as decided by validation team.
5.15.4 Testing (as per protocol) is performed at 0, 30, 60 days or more (decide by validation team) and tests acceptance criteria are as per stability specifications.
5.15.5 Test results at the time of sample storage for Hold time study serves as the initial time point of testing (i.e. “0” storage days) e.g. final granules results, bulk cores results etc.
5.15.6 Product release and validation are not contingent on the results of the Hold time study data.
5.15.7 Hold time study data is evaluated in an addition to the process validation report, and is used to establish the maximum processing hold time of the product prior proceeding to the next manufacturing step.
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