SCREENING OF RAW MATERIALS FOR TSE/BSE RISK

1.0 PURPOSE:
To provide a written procedure for screening and control of raw materials (API & Excipients) for TSE/ BSE risk.
2.0 SCOPE:
This procedure covers screening and control of raw materials (API & Excipients) for TSE/ BSE risk.
3.0 RESPONSIBILITY:
Plant Head, Manager Quality Control and Manager Quality Assurance.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil.
6.0 PROCEDURE:
6.1 The QA Department shall prepare a questionnaire to qualify suppliers with respect to BSE/TSE risk.
6.2 This questionnaire shall be approved by Manager QA.
6.3 This procedure shall include the screening and controls that are required in qualifying supplier to assure that raw materials procured are free from BSE / TSE risk.
6.4 The QA Department shall require the material Purchase department to purchase only from such manufactures who have fulfilled criteria described in this document.
6.5 QA shall provide the questionnaire to Purchase department for distribution to the manufacturers of raw materials.
6.6 Material Purchase department shall intimate to suppliers to send filled BSE / TSE Questionnaire or BSE / TSE risk certificate before sending material to XXXXXX company.
6.7 The materials Purchase department shall return the filled questionnaire / BSE / TSE risk free certificate to QA for evaluation.
6.8 The Manager Quality Assurance shall review the filled questionnaire or BSE /TSE risk free certificate received from the suppliers.
6.9 QA recommends to purchase the material from the supplier who satisfactorily filled questionnaire and meet all criteria. If not found satisfactory, QA shall send queries to the manufacturer for further clarification. Material shall not be purchased until the filled questionnaire found satisfactory.
6.10 QA shall approve the supplier based on the minimum requirement:
6.10.1 BSE /TSE risk certification or comments of BSE /TSE evaluation questionnaire.
6.10.2 By considering other criteria (Audit for all API and Primary Packing material supplier).
6.11 Supplier BSE / TSE risk shall be evaluated every year by reconfirming the above procedure.
6.12 To minimize the risk of TSE / BSE contamination the following measures shall be taken:
• Proper segregation of material between TSE / BSE free and non TSE free material (All capsules procured are certified to be BSE free)
• Difference in the color of capsules between TSE / BSE free and non TSE free shall be maintained.
• If same color of capsule have to be produced, difference in the printing on the capsules shall be maintained for easy identification.
• As an Additional Measure cleaning validation shall be done for presence of gelatin with the acceptance criteria of a maximum of 10 PPM.
• As a worst case in future, dedicated machine will be provided to minimize the risk.
7.0
REFERENCES:
Nil
8.0
ENCLOSURE:
8.1 Questionnaire for screening of supplier for TSE /BSE risk : QAGN: xxxxxx
9.0
ABBREVIATIONS:
9.1 TSE : Transmissible Spongiform Encephalopathy.
9.2 BSE : Bovine Spongiform Encephalopathy
9.3 API : Active Pharmaceutical Ingredient
9.4 QA : Quality Assurance