Qualification of Vendor for raw material in Pharma:

In pharmaceutical for purchase of raw material mainly starting raw material you have to approve the vendor.

In following circumstance need to develop the vendor:

-      When new product is developed (For new raw material)

-      As a alternative of source of the existing  raw material

-      Supply of existing vendor is not satisfactory

-      New raw material from existing raw material.

Following the procedure to qualification of new vendor:

Based on the Vendor questionnaire

Based on the R and D trial and QC analysis result

Based on Vendor Audit

Based on the Vendor questionnaire:

-        Purchase department shall identify the vendor

-        After identify the they send the vendor questionnaire

-      Along with vendor questionnaire, TSE / BSE declaration, GMO, declaration free from volatile impurities,  OVI declaration shall be provided by the  vendor

-      QA department evaluate the all the received documents.

-      Based on the evaluation of the documents they  procure the three samples.

Based on the R and D trial and QC analysis result

-        Purchase department identify the vendor and send the required specification to the vendor

-       Procure three samples from three different batches along with COA.

-      QC person shall analyze the samples as per the standard specification or the as per the requirement for the new product.

-      It samples pass in the specification, sample shall be released with COA by QC department.

-     After samples are released by QC, same shall be send to R & D for  trial if required.

-      Performance trial of these samples shall be taken in R & D and samples analysis report of trial batches results shall be recorded and submitted to QA.

-      Based on these data QA evaluate the sample

-     After successful evaluation & assessment vendor shall be qualified as approved vendor.

Based on Vendor Audit

-  Head-QA decide for conducting the audit of the facility of the manufacturer if required

-  Information about vendor audit shall be given in advance to the concern person of manufacturer/supplier in writing or through verbal communication along with Audit agenda if required.

-  Vendor audit shall be conducted by any authorized person including Designee QA or Head Operations or Head QA along with Designee purchase if required

-  During the vendor audit, auditors shall review the quality, manufacturing process, capabilities and commitment to prevent quality problems of the vendor

-   After conducting the audit report shall be prepared and it shall be shared to the vendor

-   Compliance report shall be provided by the vendor if required

      Based on the evaluation of the vendor finally approved vendor list shall be prepared.

Design Qualification in Pharma

-In Design Qualification we provide documented evidence that the premises, supporting systems, utilities and equipment have been designed for their intended purposes and in accordance with the requirements of good manufacturing practices.

     -According to the design qualification Equipment shall be designed as per GMP requirement. 

-The requirements of the user requirements specification should also be verified during the design qualification.

-Design qualification is followed by the FAT (Factory acceptance Test) and SAT (Site acceptance Test) if required.

-Design Qualification Perform prior to purchase.

-Following Check point shall be included in Design Qualification but not limited to

         

          -Basic system design 

          -Selection of Equipment / Accessories

          -Material of construction of all Accessories and Components

          -List of drawings

          -Details of Utilities

          -Safety features

Performance qualification of Equipment in Pharma

-In Performance qualification ensure that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods.

-It provides the documents evidence that the equipment perform.

- Performance qualification is performed after successful completion installation qualification and operational qualification.

-The PQ represents the final qualification of your equipment or system.

- Performance qualification include following checkpoints: 

         - Perform the operation into the equipment by using raw materials, or  substitutes 

- Processing steps including variables and tests to include conditions covering upper and lower operating limits.

-Critical process parameters 

-Challenge steps (where applicable)

         - Operating parameters and equipment limits

         - It shall cover the operating range of the critical process parameters.

         - Tests to performed to ensure quality at each production

-After completion of the performance qualification of the equipment can be used for routine manufacturing activity; however process validation shall be performed before starting the routine manufacturing activity .Process validation may be combine with the Performance qualification.

Operational qualification of equipment in Pharma

- Verifies that the equipment operates consistently within established limits and tolerances over the defined operating ranges. Studies on critical variable to include conditions encompassing upper and lower operating limits and circumstances (i.e.“worst case conditions”)

- It provides the document evidence that the equipment is operating within the pre defined range.  

-During the operational qualification Critical operating parameters should be identified.

-After successful installation of the equipment Operational qualification shall be performed.   

    -OQ protocol shall include following check points:

          - Test of operation parameters and its range (E.g Pressure range, Temperature   range, RPM of the centrifuge)

          - Testing of Alarm 

          - Check the functionality of the equipment 

          -  If any software are there then challenge of software

     -Critical operating parameters shall be identified during Operational qualification.

-Training of operators for the systems, utilities and equipment should be provided and training records maintained during operation qualification stage.

-Systems, utilities and equipment, as appropriate should be released for PQ or routine use after completion of OQ.

-The results of the OQ should be recorded in the conclusion of the report, before    PQ is started.

- SOPs for the operating of equipment shall be prepared in this stage of the qualification as personnel can follow that SOP.

     -The results for the verification of operation shall be recorded in to the reports.