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SELF INSPECTION

Self-inspection is basically a method of objective overall review of one's own operation on aspects that may have on quality effect on quality assurance. In general, self-inspection aims at identifying defects whether of critical, major or minor nature.

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SELF INSPECTION

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  1. SELF INSPECTION

  2. Quality Audit • Definition: • Quality audit is a process of examination and verification of procedures, records, and activities of a quality system that is carried out by an audit team or an internal or external quality auditor. Quality audit is considered an integral part of the quality management system and is considered as a critical component in GMP

  3. What to check? • Objective: To identify the potential discrepancies in, • Documentation • Sanitation and hygiene practices • Validation and revalidation programs • Calibration of instruments or measurement systems • Recall procedures • Complaints management • Labels control • Results of previous self-inspections verifications

  4. Who can audit? • Lead auditor is usually a senior auditor who has extensive knowledge of the firm’s operations and exhibit strong leadership qualities. • SMEs from CFT departments • Minimum graduation/Diploma and minimum five-year experience in Pharmaceutical industry • Sound knowledge of cGMP, Quality system, SOP’s, material and product standard

  5. Defining Auditor Qualification • Selected based • On their knowledge • Experience in manufacturing and QC principles as well as years of firsthand experience dealing with GMP matters. • Any other technical expertise • Auditor certification (ASQ), IRCA, ISO etc.)

  6. Pre-requisites for Auditor • Willing to consider alternate ideas for observations (Logical) • Auditor must know the process & analytical techniques • Faith, Truthful, Sincere, honest. • Tactful dealing with people

  7. Selecting Audit teams • Team is required for cover many different systems and large amount of data. • Composition of team will vary depending upon the nature and scope of the audit. • Team Size • 2 to 3 members • Team shall be formed by QA Head/Designee

  8. Limitations of Personnel in audit • Experience and knowledge, which is individual. • Emphasize on familiar issues as well as particular area

  9. Self Inspection Program Flow chart

  10. Audit Format and Approaches • Manual GMP audit methods can be divided into categories; • Checklist format • GMP regulation approach • Systems analysis method

  11. Checklist Format • Use checklist as GMP audit guides and reporting finding. • Series of questions or instructions are grouped into logical order. • Blocks may be used to record answer and space may be provided to make comments

  12. Checklist Format Advantages: • Simple, convenient and easy to use for any desired subjected area • Knowledgeable personnel may develop questions and guideline • Questions are in logical order that help auditor to detect problems • Report can be prepared in a minimum amount of time Disadvantages:- • Question may be interpreted in more than one way because of bias or hidden meaning. • Solve the devising questions is not easy task. • Limited content.

  13. Detecting Potential Problems • GMP audits find objectionable condition that is unknown to responsible production, QC, QA or management personnel. • The auditor will see whether such actions are frequent or not. From this he can identify other GMP problems • Guidelines / Regulations shall be referred.

  14. Detecting Potential Problems • Procedures / Practices must be inline with the requirements of • Regulatory Agencies (FDA, EU, CA, etc.) • Industry Guidance (ICH, ASNI, ISO, WHO, USP-NF, etc.) • Quality Manual • Site procedures (Quality System) • Key Elements for Data Integrity

  15. Interrogations during the audit • Benefits can be gained from having questions with employees. 2) Findings are communicated with affected personnel. 3) Discussion may help the employees to learn why problems happened.

  16. Reporting Audit Finding • Audit reports should contain complete details of the program, • observation detected with objective evidences/references. • Corrective Actions taken • Acceptance and review by Auditor Shall provide overall adequacy of program

  17. Final report • Must review and determine what steps need to be taken to eliminate deficiencies. • Should sincerely encourage detection of problems and express appreciation for being able to improve quality operations • May be shared with Head of each department 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.

  18. Effective Programme / Improvements • Changing SOPs • Modifying manufacturing equipment or procedure • Upgrading equipment or procedure • Improving employee training programme • Developing new or revised documentary system

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