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HOW TO CONDUCT AN INSPECTION

HOW TO CONDUCT AN INSPECTION

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HOW TO CONDUCT AN INSPECTION

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  1. HOW TO CONDUCT AN INSPECTION

  2. CONTENTS • Objectives • Scope • Qualifications of an Inspector • Qualities • Communication Skills • Inspection Process • Types of Inspection • Report Writing

  3. OBJECTIVES • To promote harmonization. • To assist government inspectors in assessing GMP compliance for cosmetics. • To assist the industries in preparation for regulatory audit.

  4. INDONESIA CAMBODIA LAO PDR BRUNEI VIETNAM MALAYSIA THAILAND SINGAPORE MYANMAR PHILIPPINES SCOPE Applies to all national regulatory authorities (NRA) of countries who are members of the Association of South East Asian Nation.

  5. THE INSPECTOR

  6. QUALIFICATIONS • Must have undergone appropriate training in the current procedures and techniques of GMP inspections. • Must have complete working knowledge of the ASEAN GMP guidelines for Cosmetics and familiar with the training modules endorsed by the ACC • Must have personal qualities of integrity, tact and character.

  7. An inspector must…. • Be able to present factual report. • Be able to communicate well. • Have a good working knowledge of the national legislation and the GMP guidelines that manufacturers are expected to comply with.

  8. An inspector must…. • Be able to offer assistance, in his or her opinion, to serve the public interest. • Be able to motivate a manufacturer to comply with GMP or correct specific deficiencies.

  9. Personal Qualities • Conform to codes of ethics and conduct • Independent/no conflict of interest • No double role as inspector and consultant • Resist attempts to influence decisions • Discrete

  10. Communication Skills Language • Use suitable language to the levels of the persons being addressed. • Be able to convey & elicit information on all occasions.

  11. Communication Skills Body Language • Same gesture can mean different things to different people from different countries. • Show interest by encouraging with a smile and a nod of the head.

  12. Communication Skills • Keep your arms open, rather than crossed. This indicates receptiveness to the answer you are being given. • Be aware and sensitive to the prevailing company culture. • Be diplomatic in your approach. • Be aware that within different countries, there may be different cultures and social behaviours that can have a major impact on your ability to communicate.

  13. INSPECTION PROCESS

  14. PRE- INSPECTION • Organize the team with a leader who is responsible for: • Planning the inspection • Leading the opening and exit meetings with the company • Preparing the deficiency and final draft report

  15. PRE- INSPECTION • Lead inspector notifies the company at least a week before. An unscheduled audit may be considered when the true extent of GMP compliance cannot be assessed otherwise.

  16. PRE- INSPECTION • Inspection team reviews the following: • Manufacturing license • Site information file • Previous inspection reports • Product dossiers • Prepares an audit plan • Aide-memoir • Checklist

  17. INSPECTION PROPER • Meeting with the company’s representatives. • The leader introduces the members of the team and acquaints himself and the team with the company’s key personnel. • Brief discussion on the purpose of the visit and gather updates from the company pertaining to plant operations • Presents the audit plan.

  18. INSPECTION PROPER • Perusal of the following documents: • Layout of site and diagrams of utilities • Self inspection/internal audit reports • Complaints file • Standard Operating Procedures

  19. INSPECTION PROPER • Walk through visual inspection • Size of the facility • Number of employees • Employee practices • Environmental conditions in and out of the plant

  20. INSPECTION PROPER • Manual and automated practices • Manufacturing flow • Method of data collection • Maintenance of building • General housekeeping • Sources of contamination

  21. INSPECTION PROPER • Team meets to discuss & prepare deficiency report.

  22. INSPECTION PROPER Project co-financed by European Union • Exit meeting with the company • Leader gives overview of the audit and its outcome. • Leader may provide the company with the deficiency report and encourages discussion. • Leader requests written response to the final deficiency report within 4 weeks from the date of receipt.

  23. It pays to listen.. • Stop talking! • Help the speaker to feel free to talk • Be approachable • Show the speaker that you are interested • Remove distractions • Try to understand the speaker’s point of view

  24. It pays to listen.. • Be patient • Hold your temper • Try not to criticize • Ask questions • Stop, look and listen

  25. TYPES OF INSPECTION • Routine/ Regular * • Follow-up / Verification * • Special /Surveillance * • Quality Systems review * Terminology above are interchangeable within the NRA inspectorate system to align with the present quality system in place

  26. Routine Inspection Done when the manufacturer: • Is newly established • Requests renewal of license to operate • New product line or new product • Has made key changes in equipment, personnel, premises • Has a history of non-compliance • Has not been inspected for the past years

  27. Follow-up Inspection • Made to monitor the results of corrective actions. • Done within 6 weeks to 6 months after initial inspection. • Limited to specific GMP requirements that have not been observed or inadequately implemented.

  28. Special Inspection • Made to carry out spot checks following complaints including allergic reactions or recalls related to quality defects in products. • Establish how a product is manufactured as a pre-requisite for marketing approval.

  29. Special Inspection • Investigate specific operation. • Advise manufacturer on regulatory requirements.

  30. Quality Systems Review • To assess a quality assurance system that has been shown to operate satisfactorily.

  31. ANNOUNCED & UNANNOUNCED INSPECTIONS • Depends on type of inspection • Announced: • comprehensive inspection • Unannounced: • routine inspection * • follow-up inspection * • special inspection * • quality systems review * Terminology above are interchangeable within the NRA inspectorate system to align with the present quality system in place

  32. FREQUENCY OF INSPECTION Based on the degree of risks to consumers such as: • Type of products manufactured • Result of previous GMP inspection/company’s compliance history • Product complaint or recalls since last inspection • Results of product testing by NRA laboratories or other agencies.

  33. FREQUENCY OF INSPECTION • NRA surveillance • Significant changes within the company, ie, key personnel, buildings, key equipment and products

  34. DURATION OF INSPECTION An inspection may take a day or up to several days and involves a detailed examination of the operations and procedures of the factory. The initial inspection of a new manufacturer must be thorough and comprehensive; a minimum of two full days is therefore usually allocated to a full manufacturer inspection.

  35. DURATION OF INSPECTION • Depends on type of inspection • Inspectorate resources (e.g. workload, number of inspectors) • Size of the company • Purpose of the visit • Number of inspectors

  36. REPORT WRITING

  37. CONTENTS • GENERAL INFORMATION OF THE COMPANY/FACILITY • BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP • FINDINGS • CONCLUSION

  38. I.GENERAL INFORMATION OF THE COMPANY/FACILITY • Name of Company • Address • License to operate including validity • Products manufactured • Persons Interviewed/met during inspection • Purpose of Inspection • Date of Last Inspection

  39. II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP • Building/Premises • Site/location • Construction materials/finishes used • Process Water • Utilities

  40. II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP • Personnel • Qualifications • Adequacy in number • Training

  41. II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP • Equipment • Major equipment including capacity • Materials used for construction • Cleaning procedures (CIP)

  42. II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP • Quality Control • Adequacy of apparatus used for testing • Maintaining raw, packaging & finished product specifications • Design of the laboratory facility to suit relevant operations

  43. II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP • Documentation • Standard Operating Procedures • Batch Production Records • Master batch production records • Packaging Records • Records of Complaints & Recalls • Self-inspection Reports

  44. II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP Other documents • Calibration records • Pest Control • Training schedule • Preventive maintenance plan & records

  45. III. FINDINGS • Positive findings – morale boosters • Negative findings – deficiencies noted

  46. CLASSIFICATION OF FINDINGS Critical: There is a risk that product may not meet performance requirements or specifications. Critical observations may result from inadequate quality systems, or consist of numerous major observations in the same audit area or repeated major observations.

  47. CLASSIFICATION OF FINDINGS Major: Minimum risk that finished products may not meet performance requirements or specifications. GMP deviations are not a result on the lack of quality systems.

  48. CLASSIFICATION OF FINDINGS Minor: No risk that product will not meet performance requirements or specifications.

  49. CLASSIFICATION OF FINDINGS Observations are Opportunity for Improvement (OFI)