Finished Product Sampling SOP


1.0   PURPOSE:

1.1.            To establish a procedure for sampling of finished goods.


2.1.      It is applicable to all finished products in all sections of Production Department.


3.1.      Quality Assurance Manager
3.2.      Quality Assurance Officer
3.3.      Production Pharmacist

4.0    PROCEDURE:

4.1.      Q.A Officer after the final packaging of the product receives the request for analysis from Production Department.
4.2.      Q.A officer collects the random sample from different shipper/cartons of Finished Product, number of total packs to be collected are specified in F-07-007, (Minimum Quantity of Finished packs for Retained Sample and Stability Studies),
4.3.      Production Pharmacist enters the no. of packs taken by Q.A officer in log book of “Quantity of Retained Sample” (RSLB-05-005) and Q.A Officer will sign it after receiving the sample.
4.4.      Q.A Officer then hand over the analysis request to Q.C Analyst for analysis of finished goods.
4.5.      1 finish pack (if required more than 1) is used for test/analysis at finished product stage, and the remaining packs are retained in Retained Sample Room in QC Lab.
4.6.      Collected sample is recorded in QA register of Retained sample by QA Officer with:
4.6.1.   Product Name
4.6.2.   Mfg. Date
4.6.3.   Exp. Date
4.6.4.   No. of packs taken
4.6.5.   Date of sampling
4.6.6.   Signature
4.7.      Q.C Manager will issue the finished product test report after the sample has been analyzed as per specifications.
4.8.      Retain sample packs are stored in Retained Sample Room; maintained at temperature NMT 30oC ±2oC and NMT 60% ± 5% Relative Humidity.

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.


EVIDENCES OF RECORDS & REFERENCES
Retained Sample Register (QA Register)

FORMAL KPIs
 (Key Performance Indicators)
Entry of the retain sample in register as soon as the sample has been collected
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN
Risks
Impact



Collected sample is less than the specified sample size 
Not enough for future examination/ testing will be compromised

Always make sure to collect the exact sample as specified in F-07-007




QA Officer/
QA Attendant



Retaining of Sample is not recorded in register
No evidence for sample will be available

Entry in the register must be made as soon as the sample is retained in the room

Temp/RH not maintained in retained sample room
Product quality will be effected

Maintain required/proper temperature and humidity and record it on daily basis



No comments:

Post a Comment