Quality control, Analytical method transfer | Industrial Pharmacy | B.Pharma 7th sem Notes PDF download

Quality control, Analytical method transfer

Technology Development and Transfer of Technology- Industrial Pharmacy - B.Pharmacy 7th Semester Notes

1. Transfer of analytical methods should accommodate all the analytical testing required to demonstrate compliance of the product to be transferred with the registered specification.
2. Analytical methods used to test pharmaceutical products, starting materials, packaging components and cleaning (residue) samples, if applicable, should be implemented at the testing laboratory before testing of samples for process validation studies is performed by the RU. Process validation samples may be tested at the RU, the SU or a third laboratory.
3. A protocol defining the steps should be prepared for transfer of analytical methods. The analytical methods transfer protocol should include a description of the objective, scope and responsibilities of the SU and the RU; a specifi cation of materials and methods; the experimental design and acceptance criteria; documentation (including information to be supplied with the results, and report forms to be used, if any); procedure for the handling of deviations; references; signed approval; and details of reference samples (starting materials, intermediates and fi nished products).
4. The SU’s responsibilities for the transfer of analytical methods are to:
   • provide method-specifi c training for analysts and other quality control staff, if required;
   • assist in analysis of QC testing results;
   • define all methods to be transferred for testing a given product, starting material or cleaning sample;
   • define experimental design, sampling methods and acceptance criteria;
   • provide any validation reports for methods under transfer and demonstrate their robustness;
   • provide details of the equipment used, as necessary (part of validation report, if available) and any standard reference samples;
   • provide approved procedures used in testing; and
   • review and approve transfer reports.
5. The RU’s responsibilities are to:
   
   • review analytical methods provided by the SU, and formally agree on acceptance criteria before execution of the transfer protocol;
   • ensure that the necessary equipment for QC is available and qualifi ed at the RU site. The equipment used by the RU during the analytical transfer should meet appropriate specifi cations to ensure the requirements of the method or specifi cation are met;
   • ensure that adequately trained and experienced personnel are in place for analytical testing;
   • provide a documentation system capable of recording receipt and testing of samples to the required specifi cation using approved test methods, and of reporting, recording and collating data and designation of status (approved, rejected, quarantine);
   • execute the transfer protocol;
   • perform the appropriate level of validation to support the implementation of the methods; and
   • generate and obtain approval of transfer reports.
6. Appropriate training should be provided and all training activities and outcomes should be documented.