HANDLING OF PHARMACOPOEIAL CHANGES
PURPOSE:
To lay down a procedure for the handling of Pharmacopoeia! changes.
SCOPE:
This procedure shall be applicable for Assessment and Implementation of Pharmacopoeia changes in API, Excipient and Drug products those are handled when appearing in the official Pharmacopoeia like IP, BP,USP and Ph. Eur. etc.
This procedure is applicable at all manufacturing sites of Pharma comprises volumes of Indian markets & Rest of worlds (ROW).
Once the variations are filed & approved, the same shall be communicated to impacted departments through Revision Registered Product Information (RPI).
To prepare the Standard Operating procedure & to ensure implementation of the same.
For Domestic Market:
To communicate the changes to the affected sites immediately after receipt of changes in case of impact on product supplied in domestic market.
To verify the implementation status of Pharmacopoeia changes.
To review the change in artwork for the packaging material if any.
To initiate update/ revise artwork and packing specification as per requirement.
Plant Quality Unit
To review the implemented changes in the latest edition of the pharmacopoeia in coordination with CQC/DRA, as per applicability.
To analyze the sample as per Pharmacopoeia changes, if required.
To intimate the output of verification activity to CQC and ORA.
To update the Impacted documents as per site QMS and share with ORA in case product related to ROW market.
To take action as per evaluation of possible Pharmacopoeia changes.
Purchase department
To arrange the sample & COA from Raw material vendors as per plant requirement.
Formulation Research Development (FRD):
To evaluate formulation and advise (if required) to meet changed requirement.
Analytical Research Development (ARD):
To evaluate method and advise (if required) to meet changed requirement.
Method feasibility shall be verified, if required.
Method verification/validation/transfer requirement shall be assessed, if required.
DEFINITIONS:
Pharmacopoeia: A pharmacopoeia is a legally binding collection of standards and quality specifications for medicines used in a country or region.
PROCEDURE:
Handling of Pharmacopoeia Changes
On receipt of information regarding changes / appearance in pharmacopoeia, ORA and CQC shall review and intimate the upcoming changes in pharmacopoeia to plants related to ROW & Domestic market respectively.
Plants shall review & evaluate the specifications and test procedures for the impacted API / Excipient / finished product formulations.
In case of API / Excipient Plants shall receive of information from ORA or CQC regarding changes / appearance in Pharmacopoeia.
Plant shall verify the Pharmacopoeia changes on available sample at site. In case material is not available for verification activity or not complying with respect to subjective changes, shall inform to purchase and ask for three different batches sample of API /Excipient along with COA regarding change with copy to CQC.
Plants shall receive the three different batches sample and COA of API /Excipient from purchase.
Plants shall analyze the sample of API /Excipient with respect of Pharmacopoeia changes and evaluate the result.
Plant shall share result of three different batches sample of API /Excipient to purchase with copy to CQC.
If sample passes
If samples pass, plant shall take necessary action to update the impacted documents before implementation of subjective Pharmacopoeia changes.
Any changes in Spec/STP of FP, API, Excipients and API source to be informed to ORA before implementation, to assess regulatory impact, confirm documentation requirements for alternate API source & variation filing.
Any change related to FP & API to be implemented after approval of the variation.
For excipients, Latest edition of pharmacopoeia to be complied.
Plant shall intimate to purchase for procurement of material according to revised specification and standard test procedure.
If sample Fails
If material fails as per new changes, plant shall inform to purchase for necessary action.
Purchase shall take the decision either for procurement of material from alternate vendor or suggested to existing vendor for fulfilment of compliance requirement.
Purchase shall arrange new samples and plant shall verify the same.
In Case of Finished Product
Plants shall receive of information regarding changes / appearance in Pharmacopoeia from DRA or CQC.
Plants shall evaluate the specification/ test procedure of finished product regarding changes
Based on evaluation plant shall decide testing of batches from control samples of finished product or ongoing batches, as per Pharmacopoeia changes, if applicable.
Plant shall share the output of verification activity to CQC and DRA.
CQC and DR.A shall verify the implementation status.
If product passes
If product complies as per changes under Pharmacopeia, plant shall take necessary action to update the impacted documents before implementation of subjective Pharmacopoeia changes.
CQC shall initiate for updating/ revision of artwork, if required.
If product Fails
If product fails, Plant team/CQC shall inform to DRA and Business development department regarding necessary action for subjective product at respective sites.
DRA shall inform to respective regulatory agency, if required.
ABBREVIATIONS:
API : Active Pharmaceutical Ingredient’
ROW: Rest of World
QMS: Quality Management system
