how to conduct an inspection
DESCRIPTION
HOW TO CONDUCT AN INSPECTION. CONTENTS. Objectives Scope Qualifications of an Inspector Qualities Communication Skills Inspection Process Types of Inspection Report Writing. OBJECTIVES. To promote harmonization. To assist government inspectors in assessing GMP compliance for cosmetics. - PowerPoint PPT PresentationTRANSCRIPT
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HOW TO CONDUCT AN INSPECTION
Project co-financed by European Union Project co- financed
by Asean
EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency
2
CONTENTS1. Objectives2. Scope3. Qualifications of an Inspector4. Qualities5. Communication Skills6. Inspection Process7. Types of Inspection8. Report Writing
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OBJECTIVES
To promote harmonization.To assist government inspectors in assessing GMP compliance for cosmetics.To assist the industries in preparation for regulatory audit.
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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
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THE INSPECTOR
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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 ACCMust have personal qualities of integrity, tact and character.
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An inspector must….1. Be able to present
factual report.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.
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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.
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Personal QualitiesConform to codes of ethics and conductIndependent/no conflict of interestNo double role as inspector and consultantResist attempts to influence decisionsDiscrete
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Communication SkillsLanguage
Use suitable language to the levels of the persons being addressed.Be able to convey & elicit information on all occasions.
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Communication SkillsBody 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.
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Communication SkillsKeep 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.
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INSPECTION PROCESS
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PRE- INSPECTION1. Organize the team
with a leader who is responsible for:
Planning the inspectionLeading the opening and exit meetings with the companyPreparing the deficiency and final draft report
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PRE- INSPECTION2. 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.
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PRE- INSPECTION3. Inspection team
reviews the following:
Manufacturing licenseSite information filePrevious inspection reportsProduct dossiers
4. Prepares an audit plan
Aide-memoirChecklist
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INSPECTION PROPER1. 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 operationsPresents the audit plan.
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INSPECTION PROPER
2. Perusal of the following documents:Layout of site and diagrams of utilitiesSelf inspection/internal audit reportsComplaints fileStandard Operating Procedures
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INSPECTION PROPER3. Walk through visual
inspectionSize of the facility Number of employeesEmployee practicesEnvironmental conditions in and out of the plant
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INSPECTION PROPERManual and automated practicesManufacturing flowMethod of data collectionMaintenance of buildingGeneral housekeepingSources of contamination
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INSPECTION PROPER
4. Team meets to discuss & prepare deficiency report.
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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 PROPERProject co-financed by European Union
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It pays to listen..Stop talking! Help the speaker to feel free to talkBe approachableShow the speaker that you are interestedRemove distractionsTry to understand the speaker’s point of view
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It pays to listen..
Be patientHold your temperTry not to criticizeAsk questionsStop, look and listen
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TYPES OF INSPECTIONRoutine/ 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
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Routine InspectionDone when the manufacturer:
Is newly establishedRequests renewal of license to operateNew product line or new productHas made key changes in equipment, personnel, premisesHas a history of non-complianceHas not been inspected for the past years
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Follow-up InspectionMade 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.
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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.
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Special Inspection
Investigate specific operation.Advise manufacturer on regulatory requirements.
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Quality Systems Review
To assess a quality assurance system that has been shown to operate satisfactorily.
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ANNOUNCED & UNANNOUNCED INSPECTIONS
Depends on type of inspectionAnnounced:
comprehensive inspectionUnannounced:
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
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FREQUENCY OF INSPECTION
Based on the degree of risks to consumers such as:
Type of products manufacturedResult of previous GMP inspection/company’s compliance historyProduct complaint or recalls since last inspectionResults of product testing by NRA laboratories or other agencies.
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FREQUENCY OF INSPECTION
NRA surveillanceSignificant changes within the company, ie, key personnel, buildings, key equipment and products
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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.
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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
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REPORT WRITING
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CONTENTS
I. GENERAL INFORMATION OF THE COMPANY/FACILITY
II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
III. FINDINGSIV. CONCLUSION
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I. GENERAL INFORMATION OF THE COMPANY/FACILITY
Name of CompanyAddressLicense to operate including validityProducts manufacturedPersons Interviewed/met during inspectionPurpose of InspectionDate of Last Inspection
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II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
1. Building/PremisesSite/locationConstruction materials/finishes usedProcess WaterUtilities
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II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
2. PersonnelQualificationsAdequacy in number Training
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II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
3. EquipmentMajor equipment including capacityMaterials used for constructionCleaning procedures (CIP)
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II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
4. Quality ControlAdequacy of apparatus used for testingMaintaining raw, packaging & finished product specificationsDesign of the laboratory facility to suit relevant operations
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II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
5. DocumentationStandard Operating ProceduresBatch Production RecordsMaster batch production recordsPackaging RecordsRecords of Complaints & RecallsSelf-inspection Reports
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II. BRIEF DESCRIPTION ON MAJOR ASPECTS OF GMP
Other documentsCalibration recordsPest ControlTraining schedulePreventive maintenance plan & records
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III. FINDINGSPositive findings – morale boostersNegative findings – deficiencies noted
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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.
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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.
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CLASSIFICATION OF FINDINGS
Minor:No risk that product will not meet performance requirements or specifications.
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CLASSIFICATION OF FINDINGS
Observations are Opportunity for Improvement (OFI)
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IV. CONCLUSIONMake compliance rating Good Satisfactory Poor 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.
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