cosmetic manufacturer gmp audit

8/11/2019 Cosmetic Manufacturer GMP Audit

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* ACD ASEAN Cosmetic Directive 1

Appendix-1

REPUBLIC OF THE PHILIPPINESDEPARTMENT OF HEALTH

FOOD AND DRUG ADMINISTRATIONCivic Drive, Filinvest Corporate City

Alabang, City of MuntinlupaP H I L I P P I N E S

GMP Audit Report Format

GOOD MANUFACTURING (GMP) AUDIT REPORT

Report Number: CL month/year and number in series Reference number: State document number as received

Audited site Name and full address of the inspected site

Activities carried out by the company Manufacturer of finished cosmetic product Manufacturer of intermediate bulk Packaging Importing Others (Repacking of finished bulk)

Audited date (s) Date(s), month, year

Auditor (s)

Name of Competent Authority

Name of Inspectors(s)

Food and Drug Administration

References Manufacturers license numberRDII-MM-CL - Validity:

Products Manufactured Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc.) Face masks (with the exception of chemical peeling products) Tinted bases (liquids (liquid foundation, tinted moisturizers),

pastes, powders ) Make-up powders, after-bath powder, hygienic powders, etc. Toilet soaps, deodorant soaps, etc Perfumes, toilet waters and eau de Cologne


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Bath or shower preparations (salts, foams, oils. gels, etc.) Depilatories Deodorants and anti-perspirants Hair care products

- hair tints and bleaches (including permanent hair dyes)- products for waving, straightening and fixing,- setting products (gel for curls)- cleansing products ( lotions, powders, shampoos),- conditioning products (lotions, creams, oils),- hairdressing products ( lotions, lacquers, brilliantines)

Shaving product (creams, foams, lotions, etc.) Products for making-up and removing make-up from the face and the eyes Products intended for application to the lips Products for care of the teeth and the mouth Products for nail care and make-up (cuticle oil, nail polish remover,

nail color/paints, and other nail accessories) Products for external intimate hygiene Sunbathing products Products for tanning without sun Skin whitening products Anti-wrinkle products Others (please specify) ______________________________

Introduction Short description of the company and the activities of the company including importation of rawmaterials and/or finished products in bulk.

Date of Previous AuditName of auditors involved in the previous audit

Major changes made since the previous audit Change in organization (change in key personnel), lay-out, product line, activity, additional equipment,change of site, etc.

Brief report of the activities undertaken

Scope of AuditShort description of the inspection (product related inspection and/or General GMP inspection). The

reason for the inspection should be specified (e.g. new marketing application, routine, investigation ofproduct defect)

Inspected area(s) Each inspected area should be specified e.g. Premises and equipment, Production, Documentation,Warehouse, Quality Control


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Personnel met during the audit The names and title of key personnel met, should be specified (listed in annex)

Auditors findings and observations relevant tothe audit

Relevant headings from the ASEAN Cosmetic DirectiveNew headings maybe introduced as applicable

GMP Element Items inspected Y NRelevant

Sections to*ACD

Observations/Remark(s)

Quality ManagementSystem

1. Is there a developed, established andimplemented quality system where policiesare stated and objectives are achieved?

2. Does the QMS define the organizationalstructure, functions, responsibilities,

procedures, instructions, processes andresources for implementing the qualitymanagement?

3. Is quality system structured and adapted tothe companys activities and to the natureof its products?

4. Does the quality system operation ensure

that samples of starting materials,intermediate, and finished products aretaken, tested ( if necessary ) to determinetheir release or rejection on the basis of testresults and other available evidence relatedto quality?

1.2.1

1.2.1

1.2.2

1.2.3

Personnel


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Sections to*ACD


Organization,Qualification &Responsibilities

1. Is there an adequate number of personnelhaving knowledge, experience, skill andcapabilities relevant to their assignedfunction?

2. Are they in good health and capable ofhandling the duties assigned to them?

3. Is the organizational structure of thecompany created such that the productionand the quality control sections are headedby different persons, neither of whom shallbe responsible to the other?

4. Is the head of production adequatelytrained and experienced in cosmeticmanufacturing?

5. Does he/she have the authority andresponsibilities to manage manufacture ofproducts covering operations, equipment,production personnel, production areas andrecords?

6. Is the head of quality control adequatelytrained and experienced in the field ofquality control?

7. Is he/she given the full authority andresponsibility in all quality control duties suchas establishment, verification andimplementation of all quality controlprocedures?

2

2

2.1.1

2.1.2

2.1.2

2.1.3

2.1.3


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Sections to*ACD


8. Does he/she have the authority todesignate/ assign when appropriate,personnel, to approve starting materials,intermediates, bulk and finished productsthat meet the specification or to reject thosewhich do not conform to the relevantspecification or which were not

manufactured in accordance withapproved procedures and under thedefined conditions?

9. Are the responsibilities and authority of keypersonnel clearly defined?

10. Is there an adequate number of trainedpersonnel appointed to execute directsupervision in each section of the productionand the quality control unit?

2.1.3

2.1.4

2.1.5

Training 11. Are all personnel directly involved in themanufacturing activities appropriatelytrained in manufacturing operations inaccordance to GMP principles?

12. Is special attention given to training ofpersonnel working with any hazardousmaterials?

13. Is training in GMP conducted on acontinuous basis?

14. Are records of training maintained and itseffectiveness assessed periodically?

2.2.1

2.2.1

2.2.2

2.2.2

Premises


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Sections to*ACD


1. Are the premises for manufacturing suitablylocated, designed, constructed andmaintained?

2. Are there effective measures taken to avoidany contamination from the surroundingenvironment and from pests?

3. Is the manufacture of Household productscontaining non-hazardousmaterials/ingredients and cosmetic productsshare the same premises and equipment?(Due care should be exercised to preventcross contamination and risk of mix-up.)

4. Are there painted line, plastic curtain andflexible barrier in the form of rope or tapeemployed to prevent mix-up?

5. Are there appropriate changing rooms andfacilities provided?

6. Are toilets separated from the productionareas to prevent product contamination /cross contamination?

7. Are there defined areas provided, whereverpossible and applicable for?

a. Materials receivingb. Material samplingc. Incoming goods and quarantined. Starting materials storagee. Weighing and dispensing

3

3.1

3.2

3.3

3.4

3.4

3.5

3.5.13.5.23.5.33.5.43.5.5


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Sections to*ACD


f. Processingg. Storage of bulk productsh. Packagingi. Quarantine storage before final release

of products j. Storage of finished productsk. Loading and unloading

l. Laboratoriesm. Equipment washing

8. Are wall and ceilings, where applicableshould be smooth and easy to maintain?

9. Does the floor in processing areas have asurface that is easy to clean and sanitize?

10. Are drains of adequate size and havetrapped gullies and proper flow?

11. Are open channels avoided where possible?But if required are they able to facilitatecleaning and disinfection?

12. Are air intakes and exhausts and associatedpipe work and ducting, when applicable,installed in such a way as to avoid productcontamination?

13. Are buildings adequately lit and properlyventilated appropriate to the operations?

14. Do pipe work, light fittings, ventilation pointsand other services in manufacturing areasinstalled in such a way to avoid uncleanable

3.5.63.5.73.5.83.5.9

3.5.103.5.11

3.5.123.5.13

3.6

3.6

3.7

3.7

3.8

3.9

3.10


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Sections to*ACD


recesses and run outside the processingareas?

15. Are laboratories physically separated fromthe production areas? (preferably)

16. Are storage areas of adequate space

provided with suitable lighting, arrangedand equipped to allow dry, clean andorderly placement of stored materials andproducts?

17. Are these areas suitable for effectiveseparation of quarantined materials andproducts?

18. Are there special and segregated areasavailable for storage of

a. flammable and explosive substancesb. highly toxic substances,c. rejected and recalled materialsd. returned goods?

19. Is there a provided area where specialstorage conditions e.g. temperature,humidity and security are required?

3.11

3.12

3.12.1

3.12.1

3.12.2

Equipment

Design & Construction

1. Are pieces of production equipmentdesigned and located to suit themanufacture of the product?

2. Are the production equipment surfacescoming into contact with any in-process

4

4.1.1


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Sections to*ACD


Installation & Construction

Maintenance

material non- reactive or adsorptive?

3. Do the units of production equipmentadversely affect the product through leakingvalves, lubricant drips and throughinappropriate modifications or adaptations?

4. Are production equipment easily cleaned?

5. Are equipment used for flammablesubstances explosion proof?

6. Are equipment located to avoid congestionand properly identified to assure thatproducts do not become admixed orconfused with one another?

7. Are water, steam and pressure or vacuumlines clearly identified and where applicable,installed for easy accessibility during allphases of operations?

8. Are support systems such as heating,ventilation, air conditioning, water (such aspotable, purified, distilled) steam,compressed air and gases (example

nitrogen) identifiable and function asdesigned?

9. Are weighing, measuring, testing andrecording equipment serviced andcalibrated regularly?

10. Are all records maintained?

4.1.2

4.1.3

4.1.4

4.2.1

4.2.2

4.2.3

4.3

4.3


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Sections to*ACD


Sanitation and Hygiene

Personnel

1. Is sanitation and hygiene practiced to avoidcontamination of the manufacture ofproducts? Does it cover personnel, premises,equipment/apparatus and productionmaterials and containers?

2. Are personnel healthy to perform theirassigned duties? Is there regular medicalexamination conducted for all productionpersonnel involved with manufacturingprocesses?

3. Do personnel practice good personalhygiene?

4. Are personnel shown at any time, to have anapparent illness or open lesions that mayadversely affect the quality of products,allowed to handle raw materials, packagingmaterials, in-process materials, and finishedproducts?

5. Are personnel instructed and encouraged toreport to their immediate supervisor anyconditions (plant, equipment or personnel)that they consider may adversely affect theproducts?

6. Is direct physical contact with the productavoided to ensure protection of the productfrom contamination?

5

5.1.1

5.1.2

5.1.3

5.1.4

5.1.5

5.1.5


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Sections to*ACD


Premises

7. Do personnel wear protective and cleanattire appropriate to the duties theyperform?

8. Is smoking, eating, drinking and chewing,food, drinks and smoking materials and othermaterials that might contaminate, permitted

in production, laboratory, storage or otherareas where they might adversely affectproduct quality?

9. Are all authorized personnel entering theproduction areas practice personal hygieneincluding proper attire?

10. Are there adequate employee's washingand well-ventilated toilet facilities provided?

11. Are these separated from the productionarea?

12. Are there suitable locker facilities providedat appropriate location for the storage ofemployees' clothing and personalbelongings?

13. Are waste materials regularly collected insuitable receptacles for removal tocollection points outside the productionarea?

14. Are there methods undertaken todemonstrate that equipment, raw materials,packaging materials, in-process materials or

5.1.6

5.1.7

5.2.1

5.2.1

5.2.2

5.2.3

5.2.4


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Sections to*ACD


Equipment & Apparatus

finished products have not beencontaminated after pest control wasconducted?

15. Are equipment and utensils kept clean?

16. Are there adequate cleaning methods

employed?17. Are standard operating procedures followed

for cleaning and sanitizing of majormachines?

5.3.1

5.3.2

5.3.3

Manufacturing ProcessStarting Material

Water

Verification of Materials

1. Do the water production equipment andwater systems supply quality water?

2. Is the water system sanitized according towell-established procedures?

3. Are the chemical and microbiologicalqualities of water used in productionmonitored regularly, according to writtenprocedures?

4. Does any anomaly observed followed bycorrective action?

5. Are all deliveries of raw materials andpackaging materials checked and verifiedfor their conformity to specifications and aretraceable to the product?

6. Are raw materials clearly labeled?

7. Are all goods clean and checked for

6.1.1

6.1.1

6.1.1

6.1.1

6.1.2

6.1.2

6.1.2


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Sections to*ACD


Rejected Material

Batch Numbering System

Weighing & Measurement

Procedure & Processing

appropriate protective packing to ensurethere are no leakages, perforations orexposure?

8. Are raw materials not complying withspecifications segregated and disposedaccording to standard operating

procedures?9. Does every finished product bear a

production identification number, whichenables the history of the product to betraced?

10. Is the batch numbering system specific for aproduct and that particular batch number isnot repeated for the same product in orderto avoid confusion?

11. Is the batch number printed on theimmediate and outer container of theproduct, whenever possible?

12. Are records of batch number maintained?

13. Is weighing carried out in a defined area

using calibrated equipment?

14. Are all weighing and measurement activitiescarried out recorded and, whereapplicable, counterchecked?

15. Are all starting materials used approvedaccording to specifications?

6.1.3

6.2.1

6.2.2

6.2.3

6.2.4

6.3.1

6.3.2

6.4.1


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GMP Element Items inspected Y N

Relevant

Sections to*ACD


Dry Products

Wet Products

16. Are all manufacturing procedures should becarried out according to writtenprocedures?

17. Are all required in-process controls carriedout and recorded?

18. Are bulk products properly labeled untilapproved by Quality Control, whereapplicable?

19. Is particular attention paid to problem ofcross-contamination in all stages ofprocessing?

20. Is the handling of dry materials and productsgiven special attention? Where possible, adust-containing production system, centralvacuum system or other suitable methods isemployed.

21. Is the manufacture of liquids, creams andlotions done in a way that the product isprotected from microbial and othercontamination?

22. Is a closed- system of production andtransfer used?

23. Are pipe-lines used for delivery of ingredientsor bulk products, taken care to ensure thatthe systems are easy to clean?

6.4.2

6.4.3

6.4.4

6.4.5

6.5

6.6.1

6.6.2

6.6.3


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Relevant

Sections to*ACD Observations/Remark(s)

Labeling & Packaging

Finished Product:Quarantine & Delivery toFinished Stock

24. Is the packaging line inspected forclearance prior to operation with allmaterials and products from previouspackaging operation removed?

25. Are samples taken and checked at randomduring labeling and packaging operations?

26. Does each labeling and packaging lineclearly identified to avoid mix-up?

27. Are excess labels and packaging materialsreturned to store and recorded?

28. Are rejected packaging materials disposedoff accordingly?

29. Are all finished products approved byQuality Control prior to release fordistribution?

6.7.1

6.7.2

6.7.3

6.7.3

6.7.3

6.8.1

Quality ControlQuality Management 1. Is there a quality control system established

to ensure that products contain the correctmaterials of specified quality and quantityand are manufactured under proper

conditions according to standard operatingprocedures?

2. Is the Quality control involved in sampling,inspecting and testing of starting materials,in- process, intermediate, bulk, and finishedproducts?

7.1.1

7.1.2


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Relevant


3. Does it also include where applicable,environmental monitoring programs, reviewof batch documentation, sample retentionprogram, stability studies and maintainingcorrect specifications of materials andproducts?

7.1.2

Laboratory facilities &ControlsReprocessing

Returned Products

1. Are the methods of reprocessing evaluatedto ensure that they do not affect the qualityof the product?

2. Are additional tests performed in anyfinished product, which has beenreprocessed?

3. Are returned products identified and storedseparately either in allocated area or bymoveable barrier such as rope or tape?

4. Are all returned products tested if necessary,in addition to physical evaluation beforebeing released for distribution?

5. Are returned products, which do not complywith the original specification, rejected?

6. Are rejected products disposed accordingto appropriate procedures?

7. Are records of returned products must bemaintained?

7.2.1

7.2.2

7.3.1

7.3.2

7.3.3

7.3.4

7.3.5

Documentation1. Is there a system for preventing the use of 8.1.1


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Relevant


Specifications

any superseded document?

2. Are errors corrected such that the originalentry is not lost and corrections made aresigned and initialed?

3. Are the instructions clearly written step bystep?

4. Are all documents dated and authorized?

5. Are these made available to relevantparties?

6. Are all specifications should be approved byauthorized personnel?

7. Do the raw and packaging materialspecifications include?

a. Name of materialb. Description of the materialc. Testing parameters and acceptance

limitsd. Technical drawings, where applicablee. Special precautions e.g. storage and

safety conditions, if necessary.

8. Do the bulk and finished productspecifications include :

a. Name of productb. Descriptionc. Physical properties

8.1.2

8.1.3

8.1.4

8.1.5

8.2

8.2.1

8.2.2


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Relevant


Documents for ProductionMaster Formula

d. Chemical assay and/or microbiologicalassays and their acceptance limits; ifnecessary

e. Storage conditions and safetyprecautions, if necessary

9. Is the Master Formula available upon requestand does this document contain thefollowing information?

a. Product name and productcode/number.

b. Intended packaging materials, andstorage conditions.

c. List of raw materials usedd. List of equipment usede. In-process controls with their limits in

processing and packaging, whereapplicable

10. Are the batch Manufacturing Recordsprepared for each batch of product?

11. Does each BMR include the following?

a. Name of productb. Batch formulac. Brief manufacturing processd. Batch or code numbere. Date of the start and finish of processing

and packagingf. Identity of individual major equipment

and lines or location used

8.3.1

8.3.2

8.3.2


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Relevant


g. Records of cleaning of equipment usedfor processing as appropriate

h. In-process control and laboratory results,such as pH and temperature testrecords

i. Packaging line clearance inspectionrecords

j. Any sampling performed during varioussteps of processing

k. Any investigation of specific failure ordiscrepancies

l. Results of examinations on packed andlabeled products

12. Are records for each testing, assay result andrelease or rejection of starting materials,intermediates, bulk and finished product

maintained?

13. Do these records include?

a. Date of testb. Identification of the materialc. Supplier named. Date of receipte. Original batch number, if any

f. Batch numberg. Quality control numberh. Quantity receivedi. Date of sampling

j. Quality control results

8.3.3

Internal Audit1. Is an internal audit conducted by outside or

independent specialists or a team9


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Relevant


designated by the management for thispurpose?

2. Are there external audits done on suppliersand contractors, if necessary?

3. Is there a report made at the completion ofeach internal/external audit?

9

9

Storage, Stock handling &ControlStorage Areas 1. Is the storage area of sufficient capacity to

allow orderly storage of the variouscategories of materials and products such asstarting and packaging materials,intermediates, bulk and finished products,products in quarantine, and released,rejected, returned, or recalled products?

2. Is it designed or adapted to ensure goodstorage conditions?

3. Is it clean, dry and well-maintained?

4. Is there an area provided where specialstorage conditions are required?(temperature and humidity )?

5. Are these parameters checked andmonitored?

6. Are the receiving and dispatch bays madeto protect materials and products fromweather?

10.1.1

10.1.2

10.1.2

10.1.2

10.1.2

10.1.3


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Relevant


Receiving Products

Control

7. Is the reception area designed andequipped to allow incoming materials to becleaned, if necessary before storage?

8. Is the storage area for quarantine productsclearly demarcated?

9. Is there a sampling area provided for startingmaterials to prevent contamination?

10. Is each incoming delivery checked againstthe relevant documentation and physicallyverified by label description, type andquantity?

11. Is the consignment carefully inspected fordefects and damage?

12. Are records retained for each delivery?

13. Are there records maintained to show allreceipts and issues of products?

14. Does the issuance observe the principle ofstock rotation (first in - first out)?

15. Are there controls to prevent the tampering,altering and changing of all labels andcontainers of products?

10.1.3

10.1.4

10.1.5

10.2.1.1

10.2.1.2

10.2.1.2

10.2.1.2.1

10.2.1.2.2

10.2.1.2.3

Contract manufacturingand analysis

1. Is there a written contract between theprincipal and the contract manufacturer toclearly establish the duties and

11


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Relevant


responsibilities of each party?

2. Are the conditions of contractmanufacturing and analysis clearly defined,agreed, and controlled so as to avoidmisunderstandings?

3. Are all aspects of contracted work specifiedto obtain a quality product conforming tothe agreed standards?

11

11

Complaints & RecallsComplaints 1. Is there a person responsible for handling

complaints and decides the measures to betaken?

2. Are there written procedures describing theaction to be taken, including the need toconsider a recall, in cases of a complaintinvolving a possible product defect?

3. Are complaints involving product defectsrecorded with all the original details andinvestigated?

4. If a product defect is discovered or

suspected in a batch, are thereconsiderations on whether other batchesshould be checked in order to determinewhether they are also affected?

5. Are batches that contain reprocessedproduct from a defective batchinvestigated?

12.1

12.2

12.3

12.4

12.4


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Relevant


Product Recall

6. Are there, appropriate follow-up actions,possibly including product recall, taken afterinvestigation and evaluation of thecomplaint?

7. Are all the decisions and measures taken asa result of a complaint, recorded andreferenced to the corresponding batchrecords?

8. Are complaint records regularly reviewed foran indication of specific or recurringproblems that require attention and might

justify the recall of marketed products?

9. Is the competent authority informed if a

manufacturer is considering action,following possibly faulty manufacture andproduct deterioration, which may lead toserious safety issues?

10. Is there a system of recall from the market ofproducts known or suspected to bedefective?

11. Is there a person responsible for theexecution and co-ordination of recalls, aswell as sufficient personnel, to handle allaspects of recalls with the appropriatedegree of urgency?

12. Are there established written procedures forrecall and are these regularly reviewed?

12.5

12.6

12.7

12.8

13

13.1

13.2


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Relevant


13. Are recall operations capable of beinginitiated promptly?

14. Are the primary distribution records readilyavailable to the person(s) responsible forrecalls, and do they contain sufficientinformation of distributors?

15. Is the progress of the recall processrecorded and a final report issued, includingreconciliation between the delivered andrecovered quantities of the products?

16. Is the effectiveness of the arrangements forrecalls evaluated from time to time?

17. Is there a written instruction established toensure recalled products are stored securelyin a segregated area while awaitingdecision?

13.2

13.3

13.4

13.5

13.6

Questions raised relating to theassessment of a notification

certificate/compliance toProduct Information File (PIF)

Summary of evaluation of Parts 1-4 of the PIF. Use separate report for the PIF, if applicable. Annex 2-PIF Inspection Report

Other specific issues identified Relevant future changes announced by the companySite Master File (SMF) Assessment of SMF if any; Date of SMF

Miscellaneous


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Collection of samples, if any State the following:

name(s) of the sampled product(s), batch number(s), date, source, number of samples, and remarks on typeof packaging and storage conditions;

circumstances of sampling, e.g., suspected quality defects, routine surveillance, verification of compliancewith GMP;

Annexes attached List any annexes attachedList of Deficiencies classified intCritical, Major, and Minor

All deficiencies should be listed and the relevant reference to Appendix VI of the ACD GMP Guide for Cosmetics should bementioned.

These observations/findings may further be classified into 3 categories. Critical observations are cited when there is a riskthat product may not meet performance requirements or specifications. These may result from inadequate quality

systems, or consist of numerous major observations in the same audit area or repeated major observations. Majorobservations are noted when minimum risk that finished products will not meet performance requirements or

specifications. GMP deviations are not a result on the lack of quality systems. While minor observations are referred towhen there are no risks that product will not meet performance requirements or specifications.

All the deficiencies are related to the assessment of the marketing application, this should be clearly stated.The company should be asked to inform the inspectorate about the progress of the corrected actions and a proposed time

schedule for corrections. (See attached closed out record)Recommendation/s e.g. State if the company is recommended for initial or renewal of License to Operate.

Summary & Conclusions The inspection team should state if the company operates in accordance with the ASEAN GMP Guide for Cosmetics andmention any other item to alert requesting authority.

Name of GMP Auditor/sThe Inspection Report should be signed and dated by theInspector(s)/ Assessors who participated in the Inspection.


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