A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
Validation protocol document Validation protocol must be written before carrying out a validation activity. It should be prepared by the qualified person of concerned department and should be approved before the implementation. This document shall help to create a new validation protocol for the validation activities in different departments of pharmaceutical company. A validation protocol should contain (but not limited to) following parts.
1. Protocol approval: Protocol should be reviewed by the head of the concerned department and approved by the head of the quality assurance.
2. Objective: The aim of the validation study should be written in the objective of the validation protocol.
3. Scope: The area of the validation where the protocol will be applicable. Specific department and its area with the protocol is concerned. 4. Reason for validation: The reason behind the validation due to which the validation of process or method is being done. If the product or method is new then the “New Product” or “New Method” should be written.
5. Revalidation criteria: The situation in which we shall revalidate the process should be mentioned.
6. Responsibilities: Responsibilities of each department involved in the validation activity should be defined.
7. Reference documents: The documents those are used to complete the validation activity as specifications, standard operating procedures, BMR, BPR, method of analysis, other protocols etc. should be mentioned.
8. Procedure: How validation activity will be carried out during the process, should be written. It should also contain the operating procedures of equipments, sampling procedures, sampling time, sample quantity, analysis method, calculations, etc.
9. Deviations: All the deviations from the written procedure happened during the whole validation activity should be written. Any deviation happened should be closed before the completion of validation activity.
10 Conclusions: Validation activity should be concluded. Overall results of the validation indicating if validation passes or fails should be written in conclusion.
11. Report: Reports including the raw data should be attached as annexure. Data should be compiled by the qualified person of the concerned department and should be checked by the reviewer.
12. Report Approval: Reports should be reviewed by concerned departments and approved by the head of quality assurance. Report approval shows that the validation was completed successfully and according to the validation protocol.
Fish Bone Diagram or Ishikawa diagram (Cause and effect diagram) : Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa, who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. The defect is shown as the fish’s head, facing to the right, with the causes extending to the left as fish bones the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required. Analysis of Fish Bone diagram: Man: Educational Qualification Experience Association with Company Workload 2. Machine: Qualification Preventive Maintenance Breakdown Calibrations 3. Measurement: Inprocess checks Release testing Control sample testing Stability testing 4. Material: Raw material (API& Excipients) Packing materials Semi finished Goods 5. Method: Dispensing Sifting 6. Environment: D...
Consecutive meaning following closely with no gap or following one after another without interruption. The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so depends upon that manufacturer have to choose the number of batches to be validated. If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred. Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation. Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points requir...
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