- To provide documented evidence with high degree of assurance that the manufacturing process is capable of producing the finished product consistently of required quality, meeting its predetermined specifications and quality attributes.
- This process validation protocol is applicable to carry out process validation of Name of the Product for first three consecutive commercial batches in view of the requirements of Name of market
- Quality Assurance : Preparation, review and approval of process validation protocol.
- R&D : R&D to approve the process validation protocol
- Production : Production to approve the process validation protocol.
- Quality Control : QC to approve the process validation protocol.
- PDL : To review the process validation protocol.
- IPQA : Sampling of samples as per the sampling plans discussed in this process validation protocol.
- Engineering : To provide support with respect to utilities and equipment
- Validation Team Members
Validation team shall comprise of the representatives from following functions:
- The validation team shall be authorized by Head-QA or his/her designee as per the format attached as Annexure
- Quality Assurance
- In-process Quality Assurance
- Quality Control
- Process Development
- Write the Abbreviations here.
- Pre-requisites for Validation
- Process Equipment
- All equipment to be used for the manufacturing must be qualified as per IQ/OQ/PQ acceptance criteria. The following equipments are to be used for manufacturing of Name of the Product.
|S.No.||Equipment Name||Process Step||Equipment ID No.||Processing Area|
- Note: List of equipments used in the manufacturing process shall be prepared as per the format attached as Annexure.
- Equipment / Instruments for In-process checks
- The following calibrated equipment / Instruments shall be used for in-process checks.
|S. No.||Equipment /Instrument Name||Equipment ID. No.|
- Following specifications and Standard Test Procedures shall be referred for carrying out testing of validation samples.
- *Spec. No. *STP No.
- GTP No.: *Testing of samples shall be done as per current version of Spec., STP and GTP.
- Approved Raw Materials
- Information related to raw materials shall be recorded in Annexure.
- Manufacturing Procedure Under Validation
- Refer MFR: Manufacturing procedure: Master Formula Manufacturing procedure in brief comprise of following steps:
- Refer annexure for process flow chart.
- Critical Process Steps and Process Parameters for Validation with Justification
|Process Step||Process Parameters||Justification|
- Process Steps – Sampling and Analysis Plan with Acceptance Criteria
|Process Step||Sampling and Analysis Plan with Acceptance Criteria|
- Holding Studies
|Process Step||Holding Studies Sampling and Analysis Plan with Justification|
|Write the process stage||Write clearly Qnty of material to be kept under these studies, Frequency of sampling, test parameter, packaging type, and area of storage, test method and acceptance criteria of test method.|
- If required, revalidation shall be considered and carried out when any of the following conditions occur or prevail:
- Change in critical formulation component i.e. raw material
- Change in manufacturer or vendor of Active Pharmaceutical Ingredient
- Change in critical specifications of the product
- Change in manufacturing process which may affect the quality of the products.
- Change in the facility and /or plant (location or site)
- Change in batch size, if more than ten times of the present batch size
- Note: In case of the requirements for revalidation, because of above mentioned reasons, the validation of the critical steps shall be undertaken through addendum protocol to this protocol or a separate protocol.
- Deviations and Investigations
- Any deviation to this protocol and thereupon investigation shall be recorded as per SOP and investigation on out-of-specification test results shall be recorded as per SOP.
- Validation Report
- Based on the outcome from this validation study, a report shall be prepared by Quality Assurance and Quality Control persons. This validation report shall be reviewed and then approved by all functional
heads of all the concerned departments.
- Reference Documents
- In-process Specifications (write the doc name)
- Exhibit Batch Summary Report
- GTP No.:
- List of Annexures / Formats Attached (the following documents are written as annexure format during protocol preparation )
- Validation team members Annexure
- Equipment list Annexure
- Approved raw materials list Annexure
- Process flow chart Annexure
- Critical process variables Annexure
- Sampling plan and analytical data compilation for dry mixing Annexure
- Environmental monitoring record (holding studies) Annexure
- Process validation report cover page Annexure
- Process validation report approval sheet Annexure
- Process validation report Annexure