Analysis and Release Procedure: Purpose
Analysis and Release Procedure, The purpose of this procedure is to establish an appropriate system for analysis of intermediate stage sample (i.e. powder, granules, core tablet) and semi-finished (bulk) products (i.e. coated tablet, filled capsule) from production department for ensuring the quality by subsequent testing as well as releasing intermediate stage sample for next processing stage and semi-finished (bulk) products for packaging.
Scope:
This procedure is applicable for intermediate and semi-finished (bulk) products manufactured in general block at XX Pharmaceuticals Limited.
Definitions / Abbreviation:
Standard Operating Procedure (SOP): Standard Operating Procedure.
[] QC: Quality Control.
[] COA: Certificate of Analysis
[] SAF: Sampling Advice Form
[] Mfg. Date: Manufacturing Date
[] Exp. Date: Expiry Date
[] XX: Current version of SOP
[] Bulk Product: Any product which has completed all processing stages up to, but not including, final packaging.
[] Batch (or Lot): A defined quantity of material or product processed in one process or series of processes so that it could be expected to be homogeneous.
Responsibilities:
Sr. Executive/Executive, QC
[] To ensure that the instructions of this procedure are correctly followed.
[] To maintain the records properly as per SOP
Executive, QA
[] To perform sampling.
[] To provide SAF and sample to QC for analysis.
[] To receive report from QC dept. after completion of analysis.
Manager, Quality Control
[] To ensure that this procedure is kept up to date.
[] To confirm that the SOP reflects the required working practices.
[] To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
Head of Quality Assurance
[] Approval of the SOP.
[] To ensure the overall implementation of the SOP.
Procedure:
General Precaution(s):
[] Check the calibration status of the instruments to be used.
[] Check the validity of the working standard to be used.
[] Do not return any bulk sample to production unit to avoid batch/product mix-up.
[] Transfer excess sample to ‘Sample for Disposal’ place after approval.
Intermediate and Semi-Finished (bulk) Product Test Plan:
[] Before starting analysis ensure the test plan as Annexure-II.
[] In case of ready to fill pellets for capsule, carry out potency calculation by using assay result of representative lot of raw material & average filled weight (taken from in-process result of encapsulation stage). Dissolution test result will be taken from representative lot of raw material.
[] Perform assay & dissolution test in every 10th batch of regular commercial batch and process validation batch in case of ready to fill pellets for capsule.
Receiving and analysis:
[] Executive, Quality Assurance will collect sample of intermediate and semi-finished (bulk) product maintaining the SOP of intermediate and semi-finished (bulk) products sampling procedure.
[] Quality Assurance will provide test sample to QC according to ‘Intermediate and Semi-Finished (bulk) Product Test Plan’ (as per Annexure-II).
[] Executive, Quality Assurance will send test sample along with the Sampling Advice Form (SAF).
[] After receiving the sample, QC Executive will put the Lab. Control No. on the SAF and record all necessary information in ‘Intermediate and Semi-Finished (bulk) Product Log Register’ (as per Annexure-I).
[] After proper entry in the log book, QC Executive will keep the sample in the designated place of ‘Sample Receiving Room’.
[] QC In-charge/Sr. Executive, QC will assign the work and issue the finished product analytical work sheet to QC Sr. Executive/Executive with initial and date on every page and enter the worksheet issued by (initial and date) in the ‘Intermediate and Semi-Finished (bulk) Product Log Register’ (as per Annexure-I).
[] Sr. Executive/Executive, QC will take sample from sample receiving room and test the sample against the respective approved method of analysis.
[] Sr. Executive/Executive, QC will follow ‘Intermediate and Semi-Finished (bulk) Product Test Plan’ (as per Annexure-II) or as per requirement of SAF for analysis.
[] Record all analytical raw data and make calculation in the analyst logbook (Annexure-V) with attachment of required printout of weight(s).
[] Record the results in the work sheet with attachment of required raw data.
[] Carry out the test for assay of single sample preparation.
[] In case of instrumental analysis carried for testing, fill the instrument log properly.
[] Compare the results with the specification.
[] In case where test results go out of specification, report to designated personnel. Analysis may be repeated with proper authorization.
Release:
[] Sr. Executive/Executive, QC will compile the test report and prepare COA (as per Annexure-IV).
[] Sr. Executive/Executive, QC will check the test report, analyst log book, worksheet and COA.
[] In-charge, QC will verify the test report and approve COA if all results comply with the respective specifications.
[] If the test result does not comply with the specification follow the SOP for handling of out of specification.
[] After completion of the test, transfer left over sample in specified place labeled as “Under Test Samples” until the batch is approved.
[] After approval of the batch, transfer the excess sample to a place labeled as “Sample for Disposal” by making necessary entry in sample disposal register.
[] Sr. Executive/Executive, QC will input the necessary data in finished product trend analysis.
[] Send the approved test report with SAF and COA to Quality Assurance.
Find All Annexure Here
Annexure-I : Intermediate and Semi-Finished (bulk) Product Log Register
Annexure-II : Intermediate and Semi-Finished (bulk) Product Test Plan
Annexure-III : Finished Product Analytical Worksheet
Annexure-IV : Certificate of Analysis
Annexure-V : Analyst Logbook