Follow
1.0 OBJECTIVE : To provide guidelines for acceptance of supplier’s results on certificate of analysis.
2.0 SCOPE : This procedure is applicable to release of raw materials, where there is no or insufficient testing facility for all test parameters to determine the quality of the material.
3.0 RESPONSIBILITY
3.1 It is the responsibility of QC Department for acceptability of supplier results based on certificate of analysis given in this procedure.
3.2 It is the responsibility of QC Department for revision, control, implementation and management of this SOP in due time.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 N/A PROCEDURE
6.0 General requirement
6.1.1 Executive Director- Quality shall decide on whether the supplier is capable of complying with Beximco Pharma’s requirement; prior to accept a specific supplier and material on the basis of their approved certificate of analysis.
6.1.2 A minimum of all Identification tests must be performed for the materials which will be accepted on the basis of supplier’s certificate of analysis.
6.1.3 Critical testing parameters such as Assay, water content, Impurity content, Loss on drying, particle size, optical rotation, color of solution, appearance, density etc. that has significant effect on the material’s quality as well as on the manufacturing process must meet the latest authorized specification of BPL for any kind of raw material.
6.1.4 The materials that will be accepted on the basis of the certificate of analysis from supplier’s end, may be released as per the SOP no QC007 and may be also retested as per the SOP no QC025.
6.1.5 If there is any case, where the data on the certificate of analysis conflicts with the analytical specifications and present analytical practices of BPL, all the relevant decisions regarding quality of the material shall be determined by the Quality Assurance Head.
6.1.6 After completion of full testing of at least 3 batches / lots of an API and 3 batches/lots of an excipients, reduced testing of any material from a specific supplier can be done. In this case, identification and the critical tests must be done on each batch/lot and data of the other parameters should be taken from the supplier’s certificate of analysis.
6.2 Initial Justification Approval will be given by Executive Director- Quality after reviewing the supplier’s quality history and their competence, as follows:
6.2.1 Suitable certificate of analysis includes the following criteria:
6.2.1.1 A Certificate of analysis having detailed information of quality tests and result together with logical specification.
6.2.1.2 Confirmation that certificates of analysis available from the supplier meets the requirements of BPL Specification.
6.2.1.3 Confirmation that the process to generate the certificate of analysis accurately transfers the correct test results for that batch.
6.2.1.4 Assurance that adequate change control procedures are in place to manage changes to specifications and test methods, e.g Pharmacopoeial changes.
6.2.2 Assurance that the supplier has a satisfactory quality history for the material under review. This should consider quality of all relevant documentation as well as the quality of the material. This assurance should include:
6.2.2.1 A minimum of one year’s satisfactory quality history (at least of three manufacturing batches) of supply from the manufacturing site.
6.2.2.2 A review of complaints handling, particularly assurance that complaints have been satisfactorily investigated, properly documented, maintained and that appropriate corrective/preventive action has been taken.
6.2.2.3 A complete review of BPL rejections and of any batches accepted which have failed to meet the specification fully.
6.2.2.4 A review of any problem found within BPL, when material has been used.
6.2.3 A satisfactory comparison of the supplier’s results with data generated. The review should be made using:
6.2.3.1 Documented acceptance criteria established and justified before the work commences.
6.2.3.2 At least three different batches of the mentioned supplier.
6.2.4 A report will be compiled giving all the data included in sections 6.3.1 to 6.3.3 and confirming which test results may be accepted using the supplier’s certificate of analysis.
6.3 Maintenance and Post-Justification
In order to maintain approval to accept results from certificate of analysis for a specified material and supplier, Executive Director-Quality will assess the periodic review in accordance with defined ‘Supplier Performance Review procedure’ & the supplier continues to meet BPL requirements.
6.3.1 Periodic assessment of quality data will be performed on at least an annual basis for the API and at least once in two years for excipients & primary packaging materials.
The assessment will include:
6.3.1.1 Supplier quality history since the previous review.
6.3.1.2 A summary of the most recent audit/questionnaire report.
6.3.1.3 A comparative study and trend analysis of monitored batches since the previous review.
6.3.2 Periodic full testing will be implemented to the recommended frequency.
6.3.3 If there is any case rises, where the data on the certificate of analysis conflicts with the analytical specifications of BPL, all the relevant decisions regarding quality of the material shall be determined by the through review of the Quality head.
6.3.4 Following notification of problems by the supplier or identification of problems by the BPL, a written review will take place to assess the continued acceptance of the supplier’s test data. Examples of problems include:
– Batch rejections.
– Certificate of analysis errors.
– Poor audit findings
– Significant complaints.
If there is doubt about the supplier’s ability to test and report test data appropriately, full testing is recommended immediately by Quality Control BPL, until further confidence is gained.
