Retesting of all Approved Raw Materials

1.0 OBJECTIVE :

To provide a standard procedure for Retesting of all Approved Raw Materials.

2.0 SCOPE :

This procedure is applicable for scheduling, sampling and retesting of all raw materials.

3.0 RESPONSIBILITY :

Warehouse officer  : To schedule and intimate Quality Control Department and storage/shifting at designated place.

Quality Control Chemist and above: To sample, retest and conclude

4.0 ACCOUNTABILITY:

Quality Control Head

5.0 PROCEDURE :

All raw material used in products bear a date (Retest date), after which the material will not be used without further testing.

5.1 Frequency for retesting of Raw Materials  is as follows,

Active Materials (Except: Vitamins, Enzymes and Antibiotics)--- One year from initial analysis

Excipients, except colours, flavours---Two year from initial analysis

Flavours, Vitamins, Enzymes and Antibiotics---Six months from initial analysis

Colour---One year from initial analysis

Empty hard Gelatin capsule shells---One year  from initial analysis

Retest date shall be mentioned on “Approved Label” when the material is approved.

5.3 Get identified raw materials for retesting by warehouse department.

5.4 Prepare a list of such Raw materials in last week of every month for retest date of next month and share the information to Quality Control Department.

5.5 Deface/ tear the Approved label and affix Quarantine label on the container of retest material.

5.6 Shift raw material for retesting from “Approved Material Area” to “Quarantine Area” (change the status of material).

5.7 Do not perform Retest of material, if cost of analysis is more than approximate cost of balance stock of material.

5.8 Dispose the material as per Disposal of Laboratory Waste – SOP

5.9 Prepare Retest intimation.

5.10 Receive intimation from Warehouse department.

5.11 On receipt of intimation, enter the details in Retest Raw Material register.

5.12 Assign the Analytical Report number in Retest Raw material Register.

5.13 Carry out sampling of Raw Materials as per Sampling of Raw material -SOP

5.14 Allocate the sample to analyst for the analysis based on priority.

5.15 Sampling quantity of retest material shall be decided based on the tests to be carried out for retesting of material and it shall be mentioned in respective specification

5.16 Analyze Raw material as per Pharmacopoeia or In-house specification.

5.17 Critical tests which are specified for retesting in respective specification shall be carried out for retesting.

5.18 If material meets the specification then material is approved.

5.19 Write the analytical result after analysis in worksheet and submit to competent technical staff for approval of report.

5.20 Approve the raw material in ERP system as per regular approval procedure.

5.21 No sample shall be preserved as ‘Control Sample’.

5.22 Affix the Approved label (on green coloured paper) manually with new Re-testing date on the Bags/ Container (Annexure No.:02).

5.23 If the retest material is not complied with specification, reject the raw material in ERP system as per regular approval procedure.

5.24 Affix the Rejected label (on red coloured paper) on the Bags / Container (Annexure No.: 03).

5.25 Retest due date should not be more than expiry date.

5.26 In case if expiry date falls before retest date then the same expiry date shall be considered for further retesting date of the material.

5.27 Only three retesting’s are allowed, beyond this treat the material as Rejected.

 6.0 ABBREVIATIONS:

Abbreviation Expanded form

SOP Standard Operating Procedure

No. Number

QC Quality Control

7.0 ANNEXURES:

Annex. No.               Title

01 Retest Raw Material Register

02 Approved (Retested Material) Label

03 Rejected (Retested Material) Label 

8.0 SOP REFERENCES

World Health Organization WHO Technical Report Series No. 961, 2011, Annex 3 Good Manufacturing Practices for Pharmaceutical Products: Main principles.

EU Guideline for Good Manufacturing Practice for Medicinal Products for Human and Veterinary use., 2014, Volume 4, Part-I, Chapter 6: Quality Control. Annexure- 8.

PIC/S – Guide to Good Manufacturing Practice for Medicinal Products – 15 January 2009 (ANNEX-8).