Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 1 HOW TO CONDUCT AN INSPECTION

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 2 CONTENTS 1. Objectives 2. Scope 3. Qualifications of an Inspector 4. Qualities 5. Communication Skills 6. Inspection Process 7. Types of Inspection 8. Report Writing

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 3 OBJECTIVES To promote harmonization. To assist government inspectors in assessing GMP compliance for cosmetics. To assist the industries in preparation for regulatory audit.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 4 SCOPE SCOPE Applies to all national regulatory authorities (NRA) of countries who are members of the Association of South East Asian Nation. BRUNEI VIETNAM PHILIPPINES CAMBODIA INDONESIA THAILAND MALAYSIA MYANMAR LAO PDR SINGAPORE

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 5 THE INSPECTOR

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 6 QUALIFICATIONSQUALIFICATIONS 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 7 An inspector must…. 1. Be able to present factual report. 2. Be able to communicate well 2. Be able to communicate well. 3. Have a good working knowledge of the national legislation and the GMP guidelines that manufacturers are expected to comply with.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 8 An inspector must…. 4. Be able to offer assistance, in his or her opinion, to serve the public interest. 5. Be able to motivate a manufacturer to comply with GMP or correct specific deficiencies.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 10 Communication Skills Language Use suitable language to the levels of the persons being addressed. Be able to convey & elicit information on all occasions.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 13 INSPECTION PROCESS

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 14 PRE- INSPECTION 1. 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 15 PRE- INSPECTION 2. 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 16 PRE- INSPECTION 3. Inspection team reviews the following: Manufacturing license Site information file Previous inspection reports Product dossiers 4. Prepares an audit plan Aide-memoir Checklist

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 17 INSPECTION PROPER 1. 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 18 INSPECTION PROPER 2. Perusal of the following documents: Layout of site and diagrams of utilities Self inspection/internal audit reports Complaints file Standard Operating Procedures

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 19 INSPECTION PROPER 3. Walk through visual inspection Size of the facility Number of employees Employee practices Environmental conditions in and out of the plant

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 20 INSPECTION PROPER Manual and automated practices Manufacturing flow Method of data collection Maintenance of building General housekeeping Sources of contamination

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 21 INSPECTION PROPER 4. Team meets to discuss & prepare deficiency report.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 22 5.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. INSPECTION PROPER Project co-financed by European Union

Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 23

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 24 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 25 It pays to listen.. Be patient Hold your temper Try not to criticize Ask questions Stop, look and listen

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 26 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 27 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 28 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 29 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 30 Special Inspection Investigate specific operation. Advise manufacturer on regulatory requirements.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 31 Quality Systems Review To assess a quality assurance system that has been shown to operate satisfactorily.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 32 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 33 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 34 FREQUENCY OF INSPECTION NRA surveillance Significant changes within the company, ie, key personnel, buildings, key equipment and products

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 35 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 36 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 37 REPORT WRITING

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 38 CONTENTSCONTENTS I. GENERAL INFORMATION OF THE COMPANY/FACILITY II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP III. FINDINGS IV. CONCLUSION

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 39 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

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 40 II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP 1.Building/Premises Site/location Construction materials/finishes used Process Water Utilities

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 41 II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP 2. Personnel Qualifications Adequacy in number Training

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 42 II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP 3. Equipment Major equipment including capacity Materials used for construction Cleaning procedures (CIP)

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 43 II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP 4. Quality Control Adequacy of apparatus used for testing Maintaining raw, packaging & finished product specifications Design of the laboratory facility to suit relevant operations

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 44 II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP 5. Documentation Standard Operating Procedures Batch Production Records Master batch production records Packaging Records Records of Complaints & Recalls Self-inspection Reports

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 45 II.BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP Other documents Calibration records Pest Control Training schedule Preventive maintenance plan & records

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 46 III.FINDINGS Positive findings – morale boosters Negative findings – deficiencies noted

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 47 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 48 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.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 49 CLASSIFICATION OF FINDINGS Minor: No risk that product will not meet performance requirements or specifications.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 50 CLASSIFICATION OF FINDINGS Observations are Opportunity for Improvement (OFI)

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 51 IV.CONCLUSION Make compliance rating  Good  Satisfactory  Poor and disclaimer and disclaimer e.g Findings cited during the inspection are based on random sampling and it is not an exhaustive list for corrective action. There may be other non compliance in the area inspected / not inspected. It is the manufacturer’s responsibility to keep abreast with the changes in GMP and to be in compliance at all time.

Project co-financed by European Union Project co- financed by Asean EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency 52