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Quality Audit

Quality audit in pharmaceutical industries. General study overview

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Quality Audit

  1. 1. M.Pharm, 1st Sem Seminar Sub - DRA & IPR Topic - Quality Audit Presented by - Satyaki Aparajit Mishra Regd No - 1561611001 School of Pharmaceutical Sciences, S‘O’A University
  2. 2. Definition [1]:- Quality audit means a systematic examination of a quality system. Quality audits are typically performed at defined intervals. Any failure in their proper implementation may be published publicly and may lead to a revocation of quality certification.
  3. 3. Objectives [2] :- Pharmaceutical manufacturers commonly use audits as an effective mechanism to verify compliance with GMP. Audits can be used to establish a high degree of confidence to remain under an adequate level of control by managements. Audits are intended to verify that manufacturing and Control systems are operating under a state of control.
  4. 4. Designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions Performed routinely as well as on special occasions, e.g. if any complaint arises or repeated rejections occur ...continued
  5. 5. Self Inspection Team [2]:- Management appoints a team from the staff or from outside having competent knowledge to carry out the inspection. The team can detect any shortcomings in the implementation of GMP and recommends necessary corrective measures. Generally, people with expertise in the field of QA/QC, manufacturing and production parameter, & inventory control are chosen.
  6. 6. Frequency of Self inspection [1]:- Depends on the basis of the requirement of the company. Sometimes, carried out partially or completely but a complete inspection must be done at least once a year. In addition, it is carried out on special events like product recall, repeated rejections or sudden announcement of inspection by authorities.
  7. 7. Items for Self Inspection[1] :- • Personnel • Premises including personnel facilities • Maintenance of buildings & equipment • Quality Control • Documentation • Sanitation and hygiene • Validation and revalidation programmes • Recall procedures • Complaints management • Labels control Inspection of at least following items must be done as prescribed by the WHO text of GMPs :-
  8. 8. Check-List for Self inspection[1] :-
  9. 9. Advantages :- Simple, convenient and easy to use for any desired subjected area. Questions are in logical order that help auditor to detect problems. Report can be prepared in a minimum amount of time.
  10. 10. Management must review the final reports and determine what steps need to be taken to eliminate deficiencies. Management should sincerely encourage detection of problems and express appreciation for being able to improve quality operations. The audit reports may be shared with manger supervisor who may discuss finding with employees. The workers and supervisory personnel should be given the opportunity to explain their views and ideas about the audit findings. Final report to the management [3] :-
  11. 11. Reference :- 1. Sharma P.P ; How to Practice GMPs , 6th Edition (2010) Page 99-114 [1] 2. Pharmaceutical Quality Group; Monograph no :- 5 (revised): Pharmaceutical Auditing ; IQA2001, ISBN 0906810 68X [2] 3. Provisional Guideline ON the inspection of the pharmaceutical manufacturers in: WHO Expert committee on specification for Pharmaceutical Preparations; 32nd report, Geneva, WHO, 1992, Annex-2 (Who technical report series. No :- 823) [3]