What are the 4 types of validation?
A) Prospective validation
B) Retrospective validation
C) Concurrent validation
D) Revalidation
How many stages for process validation life cycle?
Process Design: Process design is the first stage of the process validation life cycle approach. Design the manufacturing process of the subject product based on the knowledge gained from development study, laboratory trial, process optimization study or knowledge of manufacturing similar products.
Process Qualification: During the process qualification stage of the process validation life cycle approach, the process design is evaluated to determine if it is capable of manufacturing reproducible commercial batches. This stage has two elements:
(a) Design of the facility and qualification of the equipment and utilities,
(b) Process performance qualification (PPQ) – in other words, execution of the Process Validation (PV) batches.
Continued Process Verification: The third and final stage of process validation is Continued Process Verification (CPV), the goal of this stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacturing.
How many batches will be manufactured during process validation?
A. In general, a minimum of three (03) consecutive commercial batches shall be manufactured for process validation.
B. In case of scale up / scale down batches, one (01) batch can be considered as validation batch, if there is no change in IBC, machine/equipment, process. Justification for selecting one batch as validation shall be made clear in the respective protocol.
C. Process Validation shall be performed for new/ alternative source of API/ Primary Packaging materials. In such case, a minimum three (03) consecutive commercial batches shall be manufactured with new/ alternative source of API/ primary packaging material to complete the PV.
What are the requirements to be released for distribution of process validation batch?
PV batches shall be released for distribution after the successful completion of the first two stages of the process validation (i.e. process design and process qualification).
What are the conditions for concurrent release of the PPQ/ PV batches?
• In case three (03) consecutive commercial batches are not manufactured then interim PV report shall be prepared, evaluated and batch / batches release decision can be made based on the assessment from that interim report.
• If interim report is prepared for one (01) batch then all information shall be covered as per protocol;
• If two (02) batches are considered then CPP and CQA shall be mentioned along with introduction, objective and scope, summary and conclusion
What is the stability study requirements for process validation batches?
Stability study of the PV batches shall be performed at accelerated condition for six (06) months and long term as per shelf life of the product.
Read also: Interview Questions and Answers on GMP
What is the purpose of Stability Study?
The purpose of stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product.
Which documents are prepared and reviewed by stability department?
Stability specification, method, protocol, stability schedule, monthly schedule, stability data and report.
Who will develop and provide the stability indicating method?
Analytical Research and Development.
How many years will continue long term stability study after product shelf life?
Stability study will be carried out after shelf life for another extended one year or as mentioned in respective product stability protocol at long term condition for information purpose only.
What is Validation Master Plan?
Validation Master Plan is designed to provide a planned and systematic framework within which all validation activities will cover. This document will also ensure that the manufacturing facilities comply with the applicable GMP regulations and site requirements for validation.
Who is responsible for the approval of site Validation Master Plan?
Quality Assurance Head or his/her nominee is responsible for the approval of site Validation Master Plan.
What is the period for revise core part of the VMP (Policy)?
The core part of the VMP (Policy) shall be reviewed, revised, and approved in every 3 years or as required.
Which parts are contained in VMP?
The VMP must contain, as Validation Policy/ Strategy (including re-validation policy and strategy).
Which element is supported to VMP?
The VMP is supported by SOPs, Protocols, Records and Reports.
Which cross functional team is responsible to review the validation Master Plan?
The cross functional review of Validation Master Plan is to be done by Management representatives of Validation and Calibration, Engineering, Production, Analytical Research & Development, Formulation Development, Technical Services, Quality Control, Microbiology as applicable.
Define Limit of Detection & Limit of Quantitation?
Limit of Detection: The Limit of Detection (LOD) represents the lowest detectable mass or concentration that can be observed by an analytical method.
Limit of Quantitation: The Limit of Quantitation (LOQ) represents the lowest quantifiable mass or concentration that can be reliably measured repeatedly and accurately.
Read also: Common Interview Questions and Answers on HPLC
How worst product shall be selected from the product matrix?
i) The molecule contains lowest PDE value among all molecules in the product matrix.
ii) The molecule contains lowest solubility property (in water) among all molecules in the product matrix.
Who will check the equipment after cleaning of equipment?
Qualified Visual Inspector.
How many types of sampling techniques are available for cleaning validation?
2 types: i) Swab sampling ii) Rinse sampling
What is the criteria for re-cleaning validation?
i) If any major changes in manufacturing process of existing worst product
ii) Major changes of equipment train for existing worst product
iii) Major change in equipment cleaning procedure
iv) Major change of cleaning agent composition (if use)
v) Failure of periodic cleaning verification program
Post a Comment