GMP Audit Report Format GOOD MANUFACTURING (GMP) AUDIT REPORT

Transcription

1 Appendix-1 REPUBLIC OF THE PHILIPPINES DEPARTMENT OF HEALTH FOOD AND DRUG ADMINISTRATION Civic Drive, Filinvest Corporate City Alabang, City of Muntinlupa P 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) Auditor (s) Name of Competent Authority References Products Manufactured Date(s), month, year Name of Inspectors(s) Food and Drug Administration Manufacturer s license number RDII-MM-CL - Validity: 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 ASEAN Cosmetic Directive 1

2 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 raw materials and/or finished products in bulk. Date of Previous Audit Name of auditors involved in the previous audit Major changes made since the previous audit Brief report of the activities undertaken Scope of Audit Inspected area(s) Change in organization (change in key personnel), lay-out, product line, activity, additional equipment, change of site, etc. Short 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 of product defect) Each inspected area should be specified e.g. Premises and equipment, Production, Documentation, Warehouse, Quality Control ASEAN Cosmetic Directive 2

3 Personnel met during the audit Auditors findings and observations relevant to the audit The names and title of key personnel met, should be specified (listed in annex) headings from the ASEAN Cosmetic Directive New headings maybe introduced as applicable Quality Management System 1. Is there a developed, established and implemented quality system where policies are stated and objectives are achieved? 2. Does the QMS define the organizational structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management? 3. Is quality system structured and adapted to the company s activities and to the nature of its products? Personnel 4. Does the quality system operation ensure that samples of starting materials, intermediate, and finished products are taken, tested ( if necessary ) to determine their release or rejection on the basis of test results and other available evidence related to quality? ASEAN Cosmetic Directive 3

4 Organization, Qualification & Responsibilities 1. Is there an adequate number of personnel having knowledge, experience, skill and capabilities relevant to their assigned function? 2. Are they in good health and capable of handling the duties assigned to them? 3. Is the organizational structure of the company created such that the production and the quality control sections are headed by different persons, neither of whom shall be responsible to the other? 4. Is the head of production adequately trained and experienced in cosmetic manufacturing? 5. Does he/she have the authority and responsibilities to manage manufacture of products covering operations, equipment, production personnel, production areas and records? 6. Is the head of quality control adequately trained and experienced in the field of quality control? 7. Is he/she given the full authority and responsibility in all quality control duties such as establishment, verification and implementation of all quality control procedures? ASEAN Cosmetic Directive 4

5 8. Does he/she have the authority to designate/ assign when appropriate, personnel, to approve starting materials, intermediates, bulk and finished products that meet the specification or to reject those which do not conform to the relevant specification or which were not manufactured in accordance with approved procedures and under the defined conditions? 9. Are the responsibilities and authority of key personnel clearly defined? 10. Is there an adequate number of trained personnel appointed to execute direct supervision in each section of the production and the quality control unit? Training Premises 11. Are all personnel directly involved in the manufacturing activities appropriately trained in manufacturing operations in accordance to GMP principles? 12. Is special attention given to training of personnel working with any hazardous materials? 13. Is training in GMP conducted on a continuous basis? 14. Are records of training maintained and its effectiveness assessed periodically? ASEAN Cosmetic Directive 5

6 1. Are the premises for manufacturing suitably located, designed, constructed and maintained? 2. Are there effective measures taken to avoid any contamination from the surrounding environment and from pests? 3. Is the manufacture of Household products containing non-hazardous materials/ingredients and cosmetic products share the same premises and equipment? (Due care should be exercised to prevent cross contamination and risk of mix-up.) 4. Are there painted line, plastic curtain and flexible barrier in the form of rope or tape employed to prevent mix-up? 5. Are there appropriate changing rooms and facilities provided? 6. Are toilets separated from the production areas to prevent product contamination / cross contamination? 7. Are there defined areas provided, wherever possible and applicable for? a. Materials receiving b. Material sampling c. Incoming goods and quarantine d. Starting materials storage e. Weighing and dispensing ASEAN Cosmetic Directive 6

7 f. Processing g. Storage of bulk products h. Packaging i. Quarantine storage before final release of products j. Storage of finished products k. Loading and unloading l. Laboratories m. Equipment washing 8. Are wall and ceilings, where applicable should be smooth and easy to maintain? 9. Does the floor in processing areas have a surface that is easy to clean and sanitize? 10. Are drains of adequate size and have trapped gullies and proper flow? 11. Are open channels avoided where possible? But if required are they able to facilitate cleaning and disinfection? 12. Are air intakes and exhausts and associated pipe work and ducting, when applicable, installed in such a way as to avoid product contamination? 13. Are buildings adequately lit and properly ventilated appropriate to the operations? 14. Do pipe work, light fittings, ventilation points and other services in manufacturing areas installed in such a way to avoid uncleanable ASEAN Cosmetic Directive 7

8 recesses and run outside the processing areas? 15. Are laboratories physically separated from the production areas? (preferably) 16. Are storage areas of adequate space provided with suitable lighting, arranged and equipped to allow dry, clean and orderly placement of stored materials and products? 17. Are these areas suitable for effective separation of quarantined materials and products? 18. Are there special and segregated areas available for storage of a. flammable and explosive substances b. highly toxic substances, c. rejected and recalled materials d. returned goods? 19. Is there a provided area where special storage conditions e.g. temperature, humidity and security are required? Equipment Design & Construction 1. Are pieces of production equipment designed and located to suit the manufacture of the product? 2. Are the production equipment surfaces coming into contact with any in-process ASEAN Cosmetic Directive 8

9 material non- reactive or adsorptive? 3. Do the units of production equipment adversely affect the product through leaking valves, lubricant drips and through inappropriate modifications or adaptations? 4. Are production equipment easily cleaned? 5. Are equipment used for flammable substances explosion proof? Installation & Construction Maintenance 6. Are equipment located to avoid congestion and properly identified to assure that products do not become admixed or confused with one another? 7. Are water, steam and pressure or vacuum lines clearly identified and where applicable, installed for easy accessibility during all phases of operations? 8. Are support systems such as heating, ventilation, air conditioning, water (such as potable, purified, distilled) steam, compressed air and gases (example nitrogen) identifiable and function as designed? 9. Are weighing, measuring, testing and recording equipment serviced and calibrated regularly? 10. Are all records maintained? ASEAN Cosmetic Directive 9

10 Sanitation and Hygiene Personnel 1. Is sanitation and hygiene practiced to avoid contamination of the manufacture of products? Does it cover personnel, premises, equipment/apparatus and production materials and containers? 2. Are personnel healthy to perform their assigned duties? Is there regular medical examination conducted for all production personnel involved with manufacturing processes? 3. Do personnel practice good personal hygiene? 4. Are personnel shown at any time, to have an apparent illness or open lesions that may adversely affect the quality of products, allowed to handle raw materials, packaging materials, in-process materials, and finished products? 5. Are personnel instructed and encouraged to report to their immediate supervisor any conditions (plant, equipment or personnel) that they consider may adversely affect the products? 6. Is direct physical contact with the product avoided to ensure protection of the product from contamination? ASEAN Cosmetic Directive 10

11 7. Do personnel wear protective and clean attire appropriate to the duties they perform? 8. Is smoking, eating, drinking and chewing, food, drinks and smoking materials and other materials that might contaminate, permitted in production, laboratory, storage or other areas where they might adversely affect product quality? 9. Are all authorized personnel entering the production areas practice personal hygiene including proper attire? Premises 10. Are there adequate employee's washing and well-ventilated toilet facilities provided? 11. Are these separated from the production area? 12. Are there suitable locker facilities provided at appropriate location for the storage of employees' clothing and personal belongings? 13. Are waste materials regularly collected in suitable receptacles for removal to collection points outside the production area? 14. Are there methods undertaken to demonstrate that equipment, raw materials, packaging materials, in-process materials or ASEAN Cosmetic Directive 11

12 finished products have not been contaminated after pest control was conducted? Equipment & Apparatus Manufacturing Process Starting Material Water Verification of Materials 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 major machines? 1. Do the water production equipment and water systems supply quality water? 2. Is the water system sanitized according to well-established procedures? 3. Are the chemical and microbiological qualities of water used in production monitored regularly, according to written procedures? 4. Does any anomaly observed followed by corrective action? 5. Are all deliveries of raw materials and packaging materials checked and verified for their conformity to specifications and are traceable to the product? 6. Are raw materials clearly labeled? 7. Are all goods clean and checked for ASEAN Cosmetic Directive 12

13 appropriate protective packing to ensure there are no leakages, perforations or exposure? Rejected Material Batch Numbering System Weighing & Measurement Procedure & Processing 8. Are raw materials not complying with specifications segregated and disposed according to standard operating procedures? 9. Does every finished product bear a production identification number, which enables the history of the product to be traced? 10. Is the batch numbering system specific for a product and that particular batch number is not repeated for the same product in order to avoid confusion? 11. Is the batch number printed on the immediate and outer container of the product, 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 activities carried out recorded and, where applicable, counterchecked? 15. Are all starting materials used approved according to specifications? ASEAN Cosmetic Directive 13

14 16. Are all manufacturing procedures should be carried out according to written procedures? 17. Are all required in-process controls carried out and recorded? 18. Are bulk products properly labeled until approved by Quality Control, where applicable? 19. Is particular attention paid to problem of cross-contamination in all stages of processing? Dry Products Wet Products 20. Is the handling of dry materials and products given special attention? Where possible, a dust-containing production system, central vacuum system or other suitable methods is employed. 21. Is the manufacture of liquids, creams and lotions done in a way that the product is protected from microbial and other contamination? 22. Is a closed- system of production and transfer used? 23. Are pipe-lines used for delivery of ingredients or bulk products, taken care to ensure that the systems are easy to clean? ASEAN Cosmetic Directive 14

15 Labeling & Packaging 24. Is the packaging line inspected for clearance prior to operation with all materials and products from previous packaging operation removed? 25. Are samples taken and checked at random during labeling and packaging operations? 26. Does each labeling and packaging line clearly identified to avoid mix-up? 27. Are excess labels and packaging materials returned to store and recorded? 28. Are rejected packaging materials disposed off accordingly? Finished Product: Quarantine & Delivery to Finished Stock Quality Control Quality Management 29. Are all finished products approved by Quality Control prior to release for distribution? 1. Is there a quality control system established to ensure that products contain the correct materials of specified quality and quantity and are manufactured under proper conditions according to standard operating procedures? 2. Is the Quality control involved in sampling, inspecting and testing of starting materials, in- process, intermediate, bulk, and finished products? ASEAN Cosmetic Directive 15

16 Laboratory facilities & Controls Reprocessing 3. Does it also include where applicable, environmental monitoring programs, review of batch documentation, sample retention program, stability studies and maintaining correct specifications of materials and products? 1. Are the methods of reprocessing evaluated to ensure that they do not affect the quality of the product? 2. Are additional tests performed in any finished product, which has been reprocessed? Returned Products 3. Are returned products identified and stored separately either in allocated area or by moveable barrier such as rope or tape? 4. Are all returned products tested if necessary, in addition to physical evaluation before being released for distribution? 5. Are returned products, which do not comply with the original specification, rejected? 6. Are rejected products disposed according to appropriate procedures? Documentation 7. Are records of returned products must be maintained? Is there a system for preventing the use of ASEAN Cosmetic Directive 16

17 any superseded document? 2. Are errors corrected such that the original entry is not lost and corrections made are signed and initialed? 3. Are the instructions clearly written step by step? 4. Are all documents dated and authorized? 5. Are these made available to relevant parties? Specifications 6. Are all specifications should be approved by authorized personnel? 7. Do the raw and packaging material specifications include? a. Name of material b. Description of the material c. Testing parameters and acceptance limits d. Technical drawings, where applicable e. Special precautions e.g. storage and safety conditions, if necessary. 8. Do the bulk and finished product specifications include : a. Name of product b. Description c. Physical properties ASEAN Cosmetic Directive 17

18 d. Chemical assay and/or microbiological assays and their acceptance limits; if necessary e. Storage conditions and safety precautions, if necessary Documents for Production Master Formula 9. Is the Master Formula available upon request and does this document contain the following information? a. Product name and product code/number. b. Intended packaging materials, and storage conditions. c. List of raw materials used d. List of equipment used e. In-process controls with their limits in processing and packaging, where applicable 10. Are the batch Manufacturing Records prepared for each batch of product? 11. Does each BMR include the following? a. Name of product b. Batch formula c. Brief manufacturing process d. Batch or code number e. Date of the start and finish of processing and packaging f. Identity of individual major equipment and lines or location used ASEAN Cosmetic Directive 18

19 g. Records of cleaning of equipment used for processing as appropriate h. In-process control and laboratory results, such as ph and temperature test records i. Packaging line clearance inspection records j. Any sampling performed during various steps of processing k. Any investigation of specific failure or discrepancies l. Results of examinations on packed and labeled products 12. Are records for each testing, assay result and release or rejection of starting materials, intermediates, bulk and finished product maintained? 13. Do these records include? Internal Audit a. Date of test b. Identification of the material c. Supplier name d. Date of receipt e. Original batch number, if any f. Batch number g. Quality control number h. Quantity received i. Date of sampling j. Quality control results 1. Is an internal audit conducted by outside or independent specialists or a team 9 ASEAN Cosmetic Directive 19

20 designated by the management for this purpose? 2. Are there external audits done on suppliers and contractors, if necessary? 9 Storage, Stock handling & Control Storage Areas 3. Is there a report made at the completion of each internal/external audit? 1. Is the storage area of sufficient capacity to allow orderly storage of the various categories of materials and products such as starting 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 good storage conditions? 3. Is it clean, dry and well-maintained? 4. Is there an area provided where special storage conditions are required? (temperature and humidity )? 5. Are these parameters checked and monitored? 6. Are the receiving and dispatch bays made to protect materials and products from weather? ASEAN Cosmetic Directive 20

21 7. Is the reception area designed and equipped to allow incoming materials to be cleaned, if necessary before storage? 8. Is the storage area for quarantine products clearly demarcated? 9. Is there a sampling area provided for starting materials to prevent contamination? Receiving Products Control Contract manufacturing and analysis 10. Is each incoming delivery checked against the relevant documentation and physically verified by label description, type and quantity? 11. Is the consignment carefully inspected for defects and damage? 12. Are records retained for each delivery? 13. Are there records maintained to show all receipts and issues of products? 14. Does the issuance observe the principle of stock rotation (first in - first out)? 15. Are there controls to prevent the tampering, altering and changing of all labels and containers of products? 1. Is there a written contract between the principal and the contract manufacturer to clearly establish the duties and ASEAN Cosmetic Directive 21

22 responsibilities of each party? 2. Are the conditions of contract manufacturing and analysis clearly defined, agreed, and controlled so as to avoid misunderstandings? 3. Are all aspects of contracted work specified to obtain a quality product conforming to the agreed standards? Complaints & Recalls Complaints 1. Is there a person responsible for handling complaints and decides the measures to be taken? 2. Are there written procedures describing the action to be taken, including the need to consider a recall, in cases of a complaint involving a possible product defect? 3. Are complaints involving product defects recorded with all the original details and investigated? 4. If a product defect is discovered or suspected in a batch, are there considerations on whether other batches should be checked in order to determine whether they are also affected? 5. Are batches that contain reprocessed product from a defective batch investigated? ASEAN Cosmetic Directive 22

23 6. Are there, appropriate follow-up actions, possibly including product recall, taken after investigation and evaluation of the complaint? 7. Are all the decisions and measures taken as a result of a complaint, recorded and referenced to the corresponding batch records? 8. Are complaint records regularly reviewed for an indication of specific or recurring problems 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 and product deterioration, which may lead to serious safety issues? Product Recall 10. Is there a system of recall from the market of products known or suspected to be defective? 11. Is there a person responsible for the execution and co-ordination of recalls, as well as sufficient personnel, to handle all aspects of recalls with the appropriate degree of urgency? 12. Are there established written procedures for recall and are these regularly reviewed? ASEAN Cosmetic Directive 23

24 13. Are recall operations capable of being initiated promptly? 14. Are the primary distribution records readily available to the person(s) responsible for recalls, and do they contain sufficient information of distributors? 15. Is the progress of the recall process recorded and a final report issued, including reconciliation between the delivered and recovered quantities of the products? 16. Is the effectiveness of the arrangements for recalls evaluated from time to time? 17. Is there a written instruction established to ensure recalled products are stored securely in a segregated area while awaiting decision? Questions raised relating to the assessment of a notification certificate/compliance to Product Information File (PIF) Other specific issues identified Site Master File (SMF) Summary of evaluation of Parts 1-4 of the PIF. Use separate report for the PIF, if applicable. Annex 2-PIF Inspection Report future changes announced by the company Assessment of SMF if any; Date of SMF Miscellaneous ASEAN Cosmetic Directive 24

25 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 type of packaging and storage conditions; circumstances of sampling, e.g., suspected quality defects, routine surveillance, verification of compliance with GMP; Annexes attached List any annexes attached List of Deficiencies classified intoall deficiencies should be listed and the relevant reference to Appendix VI of the ACD GMP Guide for Cosmetics should be Critical, Major, and Minor mentioned. These observations/findings may further be classified into 3 categories. Critical observations are cited when there is a risk that 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. Major observations 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 to when 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 Name of GMP Auditor/s The inspection team should state if the company operates in accordance with the ASEAN GMP Guide for Cosmetics and mention any other item to alert requesting authority. The Inspection Report should be signed and dated by the Inspector(s)/ Assessors who participated in the Inspection. ASEAN Cosmetic Directive 25

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