STANDARD OPERATING PROCEDURE HANDLING OF P&G TECHNICAL STANDARDS

STANDARD OPERATING PROCEDURE

SUBJECT :                                             HANDLING OF P&G TECHNICAL STANDARDS

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To lay down the procedure for Handling of Technical Specifications.

2.0       POLICY:

This Requirement defines the procedure for, receipt, review, understanding and implementation/ deployment at site the technical specifications for products manufactured in the site. 

3.0       PROCEDURE:

3.1       P&G site leader will receive Email notification of any new, up-versioned or archived specification or standard. 

3.2       P&G site leader will hand over the specification or standard to the site QA Head & this record is maintained as per Annexure-4. When a Contract manufacturer accepts a Specification or standard, it becomes part of the contract between P&G and the Contract manufacturer. If any modifications in technical standards, feedback will be given to the P&G by site.

3.3       The following documents are shared with the Contract manufacturer by P&G:

Formula Card (FC)

Individual Raw Material Specification (IRMS)

Individual Packaging Material Specification (IPMS)

Making Instructions (MI)

Approved Supplier List (ASL)

Master Packing material Specification (MPMS)

Illustrations (ILST)

Artworks and PSS (Shade card)

3.4       Incase there is any change in any technical standards, change should reflect in the corresponding analytical report, COA, and Lab note book etc changed.

3.5       Receipt of Technical Standards, archieving of Technical Standards and handling of Technical Standards is documented as per Annexure-4.

3.6       The technical specifications received from the principal company are reviewed and filed in separate files as per the convenience of the user, and are referred as & when required.  The BMR’s & PDR’s are photocopied as and when required and are used when the batch manufacturing and packing is done.

4.0       FREQUENCY: Whenever the Specifications/documents are received.

5.0       RESPONSIBILITY:

5.1.1    Provide CSS approved Technical Standards whenever issued to the site either by hard copy or through e-mail.

5.1.2    Provide any necessary training to all contract manufacturers to ensure complete understanding of technical information as well as format (rows and columns/structured data) of all specifications & maintain training record if required.

5.1.3    Ensure current versions of all specifications are available at site, control the version of all Technical standards in soft & share as & when required.

5.1.4    Notify originating function to initiate resolution while notifying HC Standards Office to keep the previous version active in the system until the rejected specification has been reworked and accepted by the CM.

5.1.5    Keep only current version of all Technical documents at site, shred all old version.

5.2       Contract Manufacturer (CM):

5.2.1    Responsible to review specification for completeness and for any feedback on the technical standards and any revision required.

5.2.2    Responsible to understand all technical specifications and to provide feedback within 7 business days of receiving. Each CM site has 7 days to implement approved specifications.

5.2.3    Must be capable of producing based on issued specifications:

The obsolete technical standards are filed into a separate record and marked as obsolete.

6.0       REVIEW GUIDE: Specification files.

7.0       ANNEXURE:

           

1. RM/FG Technical Standards Tracking Sheet

2. Packing material Technical Standards

3. Test Methods index (FG/RM/PM /Micro Methods)

4. For issue & retrieval.

8.0       SOPs DISTRIBUTION:

             This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x