Specification and analytical method; Purpose
The tenacity of this SOP is to define the procedure for preparation, review & approval of specification & analytical methods in quality control & microbiology laboratory.
Scope
This procedure is applicable for all raw materials (APIs and excipients), water, packaging materials and finished products of XX Pharmaceuticals Limited.
Definitions/Abbreviation:
[] COA: Certificate of Analysis
[] ERP: Enterprise resource planning
[] PMS: Packaging material specification
[] QA: Quality Assurance
[] QC: Quality Control
Responsibilities
The roles and responsibility is as follows
Officer/Executive/ Senior Executive, Quality Control
[] To confirm that this procedure is followed.
[] To retain the records properly as per SOP.
Assistant Manager, Quality Control
[] To confirm that this procedure is kept up to date.
[] To ensure that the SOP is technically sound & reflects required working practices.
[] Arrange training on the SOP to all concerned personnel.
[] To confirm implementation of the SOP after training.
Head of Quality Assurance
[] Take initiative to approval of SOP.
[] To ensure overall implementation of this SOP.
Procedure
Precaution(s)
There is no significant precaution or special instructions relating to the activities described in this SOP.
Preparation
- Enter code no. in ERP, then assign the specification reference number using the format and the analytical method reference number using the specific format
- Check whether, material is included in different Pharmacopeia [BP/EP/USP] or not.
- Prepare specification & analytical method strictly align with Pharmacopeia if the material is included in BP/EP/USP.
- Prepare specification & analytical method strictly align with Manufacturer’s guides/COA /analytical methods if the respective raw material or packaging material is not encompassed in BP/EP/USP. Include any additional test parameter as internal requirement.
- QC will share rest of the QC test sample & raw data with PD. PD will suggest to include any in-house parameter in specification (as when required/not).
- Compare specification & analytical method received from two or more suppliers; prepare specification & analytical method based on the suitable one based on feasibility study on site. Discuss with the concerned suppliers in case any difference identified.
- For printed packaging material, Officer/Executive, QC will receive copy of artwork & approved shade card/design from QA and then prepare the specification and transfer to QA for approval. After approval of the specification, QC will receive control copy of specification along with artwork and approved copy of shade card/design from QA.
- QC will prepare specification for unprinted packaging materials (Foil, Sachet, PVC/ PVDC Film etc.).
- The issue date & review date should be in the day-month-year (dd-month-yyyy) format i.e. 25-August-20YY.
- Assign two years review time for next revision from date of preparation for specifications and analytical methods.
- For draft specification & analytical method; assign one year review time from date of preparation.
- Follow respective standard format (as per concerned Annexure) for the preparation of specification & analytical method.
- Enter final specification of raw material & packaging material in the ERP.
Review
- Review specification & analytical method from draft to final one & change version no. to next one.
- Review final specification & analytical method with a proper change control procedure when any change is necessary.
- Review method & specification if there is any change in respective Pharmacopeia. Put a new version number with a new review date.
- If no modification is required at the time of review, then use subsequent review portion assign next expiry date 2 years from the review date and use the same.
Approval
- Check analytical method & specification.
- Manager, QA or Manager, QC will give approval after ensuring that each page of the document has been signed by person who prepared & person who checked specification after its finalization.
- Keep master document in QA department.
- Keep controlled copy in the QC & Microbiology department (as when required).
- Retrieve previous specification & analytical method by revised one after review. Treat previous one as ‘OBSOLETE’.
- Keep the ‘OBSOLETE’ copy in a file after stamping as ‘OBSOLETE’ in red ink
- Discard the ‘OBSOLETE’ specification least after two years from the date of obsolete.
Download All Annexure here
Annexure I Format for Packaging Material Specification
Annexure II Format for Raw Material or Water Specification
Annexure III Format for Finished Product Specification
Annexure IV Format for Analytical Method of Raw Material or Water
Annexure V Format for Analytical Method of Packaging Material
Annexure VI Format for Analytical Method of Finished Product