GMP现场检查Checklist(ENGLISH).doc

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1、6.2 Addendum B：GMP Checklist for Compliance with GMPDIRECTORATE: INSPECTORATE and LAW ENFORCEMENTROUTINE GMP:APPLICANT WITH OWNMANUFACTURING PLANTINSPECTORS CHECKLIST FOR ROUTINE GMP INSPECTION6.3 Addendum C: Cover letter for GMP inspectionsSUB DIRECTORATE: MEDICINES CONTROLROUTINE GMP:APPLICANT WIT

2、H OWNMANUFACTURING PLANTINSPECTORS CHECKLIST FOR RROUTINE GMP INSPECTIONTHIS DOCUMENT MAY NOT BE REPRODUCED FOR ANY OTHER PURPOSE THAN FOR THE USE BY AN INSPECTOR TO ASSIST DURING AN INSPECTION. IT REMAINS THE PROPERTY OF THE INSPECTORATE. NO COPY MAY BE PROVIDED TO ANY OTHER PERSON WITHOUT THE PRIO

3、R AUTHORISATION BY THE HEAD OF THE INSPECTORATE.COMPILED BY AJ VAN ZYL2 EDECEMBER 1997File no.: Type of Inspection: Routine GMPCompany name:Company address:(Postal)Company street address:Tel no.:Fax no.:RESPONSIBEL PHARMACIST:QA MANAGERPRUDUCTION MANAGER:ACTIVITIES:APPLICANT:MANUFACTURER:PACKER:DIST

4、RIBUTOR:LABORATORY:DOSAGE FORMS HANDLED:CAPSULES:LIQUIDS:S.V.P:AEROSOLS:LOZENGES:OTHER (SPECIFY):TABLETS:POWDERS:L.V.P:SUPPOSITORIES:CREAM/OINTMENTS:TYPE:CYTOTOXICS:HORMONES:PENICILLINS:BIOLOGICALS:OTHER:HOMEOPATHIC:CEPHALOSPORINS:DENTAL:VETERINARY:Staff Member:Date of contact:Time involvement: (Pre

5、paration+Travel+Inspection+Report)GG vehicle no.:KM:File no.: Type of Inspection: Routine GMPCompany name:Company address:(Postal)Company street address:Tel no.:Fax no.:RESPONSIBEL PHARMACIST:QA MANAGERPRUDUCTION MANAGER:ACTIVITIES:APPLICANT:MANUFACTURER:PACKER:DISTRIBUTOR:LABORATORY:DOSAGE FORMS HA

6、NDLED:CAPSULES:LIQUIDS:S.V.P:AEROSOLS:LOZENGES:OTHER (SPECIFY):TABLETS:POWDERS:L.V.P:SUPPOSITORIES:CREAM/OINTMENTS:TYPE:CYTOTOXICS:HORMONES:PENICILLINS:BIOLOGICALS:OTHER:HOMEOPATHIC:CEPHALOSPORINS:DENTAL:VETERINARY:Staff Member:Date of contact:Time involvement: (Preparation+Travel+Inspection+Report)

7、GG vehicle no.:KM:OBSERVATIONSA: PLANT WALK-THROUGH1. PREMISES AND EQUIPMENT (general)1.1 Layout/design Minimise: risk of errors, mix-up, cross-contamination, build up of dust or dirt.1.2 Permit effective cleaning, maintenance1.3 SOP: Rodent, insect and pest control. No insects, animals (especiallyr

8、odents) or birds, premises1.4 Building maintained in good order1.5 Waste materials continually removed, check dust bins, labels, products1.6 SOP for sanitation with schedules,methods, materials and equipmentavailable, cleaning and disinfectionon-going on a regular basis and include change rooms, was

9、h rooms, toilets and canteen1.7 Adequate lighting and venitilation, filters, gauges, dust controlled,humidity, pressure and temperatures,(filtration of outside air and airreturned to the atmosphere the minimum requirement).1.8 Environmental conditions monitored regularly and recorded.1.9 Production

10、areas-logical flow, sufficient space1.10 Production of potent products inseparate facilities(penicillins,biologicals, certain antibiotics, certain hormones and certain cytotoxics indedicated facillities)1.11 Technical poisons, (pesticides and herbicides) not in premises used for the manufacture of m

11、edicinal products.1.12 Working and in-process storage spacesufficient.1.13 Dust extraction and collection wheredust is generated.1.14 Drains have trapped gullies1.15 Pipes, fittings and the other servicesdo not create places difficult to clean1.16 Fixed pipework labeled to indicate thecontents and d

12、irection of flow.1.17 Floors, walls and ceilings: materials that facilitate cleaning1.18 Storage areas: ensure good storageconditions (clean, dry, temperature)1.19 Special storage area for flammable goods/cold rooms/low humidity rooms. Monitored and equipped withalarms to alert in case of failure.2.

13、 CHANGE ROOMS2.1 Rest rooms, smoking areas andRefreshment rooms separate fromOther areas2.2 Washing and toilet easily accessibleand appropriate for the number of users.2.3 Toilets not directly communicate withProduction or storage areas, clean andwell ventilated2.4 Soap, towels, toilet paper, (showe

14、rs where necessary)2.5 No foreign material (labels, medicine)3. RECEIVAL AREA3.1 Acceptance and dispatch bays protect materials/products from the weather.3.2 Each container/grouping of container cleaned, examined for appropriate labeling (including name, batch number, expiry date, supplier)damage an

15、d contamination,containerscompared with order document and invoice3.3 In-house nomenclature list3.4 Approved suppliers list (Reg Affairs)3.5 SOPs available: control, purchasing, receipt, storage, handling and issuing of raw materials, packaging material components, intermediate and finished products

16、.3.6 All materials handled and stored in a manner to prevent contamination, deterioration and intermixing.3.7 Only taken into stock if all relevant documentation (eg. Delivery note and COA) accompanied.3.8 Materials subject to QC quarantined and ithheld from use, until tested and released by quality

17、 control.3.9 Status clear, appropriately labeled manually or validated computer systems.3.10 Purchase, handling and control ofprimary and printed packaging materials.3.11 Receipt of starting material, and PPMrecorded, (GRV), include: date of receipt,name of material, supplier, suppliersbatch number,

18、 total quantity and numberof containers, AR number assigned.4 WAREHOUSES4.1 If not computer controlled-separate demarcated areas, preferably physically separated for: sampling, quarantine, raw materials, packaging material, intermediate and finished products, rejected, recalled and returned goods.4.

19、2 Access restricted, safe and secure conditions.4.3 Quarantined, approved or rejected goods segregated byl Physically segregated areasl Clear and easily distinguishableStatus labeling, (Labels applied tocontainers, equipment adhere well, areclear, unambiguous, completed,)l A system of control, e.g.

20、byComputers, (validated)4.4 Conditions, SOP for control and monitoring of: l Storage temperaturel Huminityl No direct lightl No exposure to air4.5 Off the floor, suitably spaced from other materials and walls4.6 Batch integrity maintained4.7 Sampled Bulk containers can be identified4.8 FIDO4.9 Re-te

21、st dates adequate system for monitoring the storage period5 SAMPLING AREA5.1 Separate area, lighting, ventilation, dust extraction5.2 Sops, equipment5.3 SOP and records for cleaning5.4 Prevent cross-contamination5.5 Samples are representative of the batch5.6 SOP include: method. Equipment to be used

22、, amount of sample, instructions for any required sub-division, type and condition of sample container, special precautions to be observed (sterile or noxious material), cleaning and storage of sampling equipment.5.7 Sample label indicating: contents, batch no date of sampling, sampler initial, link

23、 from which container the sample was taken.5.8 Care: avoid contamination, or deterioration during and after sampling, containers resealed6 RELEASED MATERIAL STORE6.1 Only QC released material6.2 Status clear6.3 Issuing of material performed by suitably trained and responsible persons, properly relea

24、sed, batch integrity maintained.6.4 Records for quantities received, issued and returned6.5 Discrepancies investigated.6.6 Appropriately labeled (status clear, not too many labels): name, internal code reference, batch number given at receipt, status, expiry/re-test date.6.7 FIFO6.8 No expired stock

25、7 REJECTED GOODS AREA7.1 Dedicated area, access controlled7.2 SOP: label, responsibility7.3 Reasons for rejecting documented8 RETURNED GOODS AREA8.1 Dedicated area, access controlled8.2 Returned from the market: destroyed unless without doubt their quality is satisfactory8.3 SOP: 9 PRINTED PACKAGING

26、 MATERIAL STORE9.1 Access controlled9.2 Separate locked areas with each component stored separately with suitable identification9.3 Supervision of a suitably trained and responsible person9.4 Issuing strict and careful control, order9.5 Avoid mix-ups: transport in sealed containers excess components

27、 destroyed if intermixing could have occurred returned components batch integrity maintained9.6 Foil: temp and humidity10 DISPENSARY10.1 Material released by QC, within shelf-life10.2 Dispensed by designated persons.10.3 Correct materials accurately weighed into clean, properly labeled containers10.

28、4 No foreign material present10.5 Each dispensed material ID and mass/volume independently checked andsigned by pharmacist/other legallyauthorized person.10.6 Materials dispensed for each batch kept together, conspicuously labelled 10.7 SOPs and records for cleaning10.8 SOP and records for calibrati

29、on and maintenance of balances10.9 Lighting and ventilation, dust extraction11 PRODUCTION AREAS11.1 Flow, walls, floors, temp, cross- contamination11.2 Addition to the mix checked and signed for by a pharmacist11.3 One product at a time per area or no risk of mix-up or cross-contamination11.4 Materi

30、als per batch kept together11.5 Areas and equipment checked for cleanliness prior to starting production.11.6 Products and materials protected from microbial and other contamination11.7 Materials, bulk containers, major itemsof equipment, rooms used labeled/identified with product or material being

31、processed, its strength and batchnumber, and stage of production.11.8 Pipelines are connected correct11.9 Access controlled11.10 Deviations controlled11.11 Yields and reconciliation of quantitiescarried out, discrepancies investigatedand explained.11.12 Critical steps signed for.11.13 In-process lab

32、oratory tests done11.14 Inappropriate labels removed fromcontainers or equipment before enteringthe manufacturing area11.15 Environmental control done11.16 Cross-contamination avoided and effectiveness checked periodically(SOP).11.17Prevent generation,dissemination of dust11.18 Authorization of star

33、t of manufacture in area11.19 Intermediate and bulk products: storage conditions, controlled periods, labels.11.20 SOP reworks11.21 Specific for oral solid dosage forms11.22 Specific for Sterile products11.23 Specific for LCO, aerosols11.24 Fixed pipework clearly labeled to indicate contents and dir

34、ection of flow.11.25 No eating, drinking, chewing andsmoking, or the storage of food, drink,smoking materials and personal medicationin manufacturing areas11.26 No direct contact between the operators hands and starting materials, intermediates and products11.27 Protective clothing apply to all (inc

35、luding visitors, maintenance personnel, senior management and inspectors) entering production areas, regularly and frequently cleaned, not worn outside the factory premises11.28 Defective equipment removed or at least clearly labeled as defective11.29 Cleaning: SOP,11.30 Equipment stored in a clean

36、and dry condition.11.31 Adequate cleaning records indicating previous product made11.32 Entries in clear legible writing, with confirmation by adding initials, no sticking, in ink or other indelible medium11.33 Records completed at the time of action11.34 Errors corrected, such a manner, original en

37、try is not lost-initialed and dated, plus reason for correction. No correction fluid12 PACKAGING12.1 Area suitable (space, light, ventilation)12.2 SOPs12.3 Packaging documents,legal requirements, labels and labeling12.4Obsolete PPM destroyed and recorded.12.5 Packaging lines well separated or physic

38、al barriers to prevent mix-ups12.6 Line-clearance/opening: check-list and signed for (eg PPM, printing operations, bulk identity) signed by pharmacist.12.7 Name and batch number displayed at packaging station or line12.8 Checked on delivery to the packaging department: quantity, identity and conform

39、ity with the packaging instructions12.9 Filling and sealing followed by labeling as quickly as possible.12.10 Printing operation (eg, code numbers, expiry dates) checked and recorded.12.11 Hand packing operations increased vigilance to prevent inadvertent mix-ups. 12.13 In process: procedures and ta

40、bulated checks signed at regular intervals for:l General appearance of the packagel Fill masses/volumes or quantity complyl Whether the packages are completel Whether the correct products and pack- Aging materials are usedl Whether any over-printing is correctl Seal integrityl Correct functioning of

41、 line monitors.12.14 Automated controls and monitors checked regularly during production run and validated from time to time.12.15 Samples taken away from packaging line not returned12.16 Completion of a packaging run: reconciliation.12.17 Special care to control return of unused packaging materials

42、12.18 Line closing: clean, removal of material, labels and unused batch-coded packagingmaterials-destroyed and destruction recorded13 FINISHED PRODUCT RELEASE13.1 Finished products quarantined until released.13.2 Documentation reconciled, complete/and sent for complete documentation audit by quality

43、 assurance: SOP.13.3 Released for sale by a pharmacist.14 QUALITY CONTROL LABORATORY (Good Laboratory Practice)1 Premises: separated from production areas, Independent from Production1 Clean: floors, walls, ceilings, extraction/ ventilation, lighting, pipes, wires. Records/logs1 Special requirements

44、 for biological/ radioactive samples/penicillin adhered to1 Properly trained, managed and motivated staff, dress code cmplies1 Sufficient space to avoid mix-ups and cross-contamination Adequate suitable storage space for samples and records1 Organogram (authorized, names) linked to job descriptions, experience1 Equipment: location, condition, logs to be kept: SOPs for each piece of equipment (operation, cleaning, calibration/checks), maintenance records1 Documentation: SOPs: sampling, retention samples and records,stab