Sop for Process Validation

1.0 Purpose

To describe the procedure for carrying out the validation of manufacturing processes thus standardizing the process sequence & parameters. This procedure will eventually ensure the maintenance of validation state & the compliance to validation requirements

2.0 Scope

This procedure deals with the validation of the critical manufacturing steps i.e. uniformity of actives in tablets, dry syrups and Injectable manufacturing to consistently produce quality products.

3.0. 3.0 Terms & Definitions

Terms	Definitions
Validation	Establishing documented evidence which provides high degree of confidence that a specific system will consistently produce a product meeting its predetermined specifications and quality.
Process Validation	To demonstrate that the critical processes involved in the manufacturing of a pharmaceutical/biological products e.g. mixing of active and inactive ingredient granulation/formulation, compression/filling, sampling and testing performed are reliable, repeatable and reproducible.
Prospective Validation	Process validation which includes these considerations that should be made before an entirely new product is introduced or when there is a change in the manufacturing process which may affect the product characteristics such as uniformity and identity of the product.
Concurrent Validation	Process validation of a product that is already in routine production.
Validation Protocol	A comprehensive and well planned documented procedure of the validation activities to be performed.

4.0 Responsibilities

a. Plant Manager

i. To supervise and ensure the execution of process validation according to schedule.

ii. To approve the validation protocol and validation report.

b. Quality Control Manager

i. To manage the analysis for the process validation.

c. Validation Manager

i. To manage the process validation

ii. To monitor the critical manufacturing processes.

iii. To arrange samples to Quality Control for testing purpose.

iv. To review the process validation protocol and report and submits to Plant Manager for approval.

v. To analyze the results received from quality control and submits the results to Plant Manager for approval.

vi. To take corrective action with the consent of Plant Manager if any deviation is observed during process validation activities.

d. Officer Validation

i. To prepare process validation protocol.

ii. To perform process validation according to procedure.

iii. To provide samples to quality control for test analysis.

iv. To compile process validation report.

5.0 Environment, Safety and Health Precautions

All the environment, safety and health precautions that are implemented in the relevant process are also applicable in validation activities

a. During process, the person responsible for validation should use all personal protective equipment.

b. Do not insert finger in any machine during operation.

c. Note any abnormal sound from machines and take remedial action to avoid the noise pollution.

d. Draw samples according to procedure by using masks and gloves.

e. During analysis all the chemical, reagents and dilutions should properly be identified.

f. The analysts during analysis should wear masks and gloves.

g. Pipette filler should be used by the analyst for filling the pipettes.

h. Dispose off the sample hygienically according to procedure for the disposal of solid waste and liquid effluents.

1.0 6.0 Procedure

Validation Manager coordinates (Through Inter office Memo) with the production department and quality control department for proper arrangement before commencing of process (concurrent/ prospective). The following are the prerequisite of the process (concurrent/ prospective) validation.

Process validation is to be performed as mentioned in schedule of validation Master plan (will be Developed by Validation Department) in coordination with relevant departments head in accordance with Process validation protocol SOP and results are recorded in Process validation Report.

Process Validation protocol comprises into:

Abstract:

Brief description of the validation protocol.

Unit Operation:

Activity to be performed.

Objective

Change Control

Responsibilities

Acceptance Criteria

Statistical Technique

Observation/Deviation encountered during validation

Impact of deviation activity.

Corrective action

Corrective action taken in response of any deviation and finally

Conclusion

a. Validation Manager prepares and reviews the Process (concurrent/ prospective) validation protocol and get these approved by the Plant manager. (All the Validation Protocol/ Reports will not be official without signatures)

b. All the equipment, material, test method, acceptance criteria, specification and the personnel must be controlled and defined in relevant validation protocol form.

c. Explain the manufacturing procedure as mentioned in the relevant BMR with the help of Flow Diagram.

d. Validation Manager monitors all the activities at the stage of mixing, granulation, compression and sampling processes to check the applicability of the procedure as mentioned in the relevant Batch Processing Record, and note down any deviation observed during manufacturing process.

e. Each process to be validated must be a specific and controlled procedure, clearly defined in the relevant documents.

f. At the end of each stage, samples will be provided to Quality Control for testing purpose as mentioned in the relevant Protocol. Quality Control analyzes the validation samples in accordance with the relevant SOP (Testing Procedure), and submits the results to Validation Manager, who reviews the results, and hands over the results to validation Department.

g. Validation Manager analyzes the analytical results with the help of Statistical Techniques as mentioned in the relevant validation protocol, and presents the results in form of graphs if applicable.

h. After the completion of the manufacturing process, Validation Manager prepares the validation report based on the validation study of at least three consecutive batches.

i. Finally the validation Report will be furnished. The validation report should cover but not limited to use of validation equipment i.e. qualified equipment through I.Q/OQ/PQ.,

The validation report comprises into following:

i. Product Name, Batch No’s, Mfg. & Exp. Date

ii. Protocol No.

iii. Results of Dose Monitoring (Weight Variation)

iv. Results of assay of 10 samples of all stages

v. Calculation of all the Analytical Results with the help of Statistical Techniques (if required)

vi. Graphical presentation of the results (if applicable)

vii. Observation