The World Bank. Aide Memoire for use during GMP inspections

Transcription

1 The World Bank e for use during GMP inspections The World Bank Procurement of Health Sector Goods Contact persons: 0

2 1. General information about the manufacturer Name of manufacturer Physical address Postal address Telephone number Fax number Summary of activities Contact person(s): Person responsible for Production Person responsible for Quality Assurance Person responsible for Quality Control Other persons met: Names of inspectors: Date of inspection: Central: State: Independent Expert: Products/dosage forms inspected (e.g. tablets, small volume injections): 1

3 Note: This is an abbreviated aide memoire, and focuses more on the gaps identified between WHO GMP and Schedule M, and is to be used in addition to the Schedule M checklist. Item Checks Key points 1 Quality Assurance Comprehensive Deviations Change control Is there a comprehensive QA system? Are deviations controlled through a procedure? Are changes controlled, recorded and approved? 2 GMP All resources Personnel Premises and space Equipment and services Materials Containers and labels Procedures and instructions Storage and transport Laboratory Training Records maintained Traceability Recalls Complaints Quality defects investigated 3 Sanitation High level Personnel Premises Equipment Materials Containers Comprehensive programme Wash of hands Avoid direct contact Protective clothing Is there overall compliance with the objectives of GMP? Are there appropriate procedures, records and evidence of a high level of cleanliness covering different aspects? 2

4 4 Qualification and validation Validation master plan. Defined responsibility Cleaning procedures. Does the manufacturer have a validation policy described in a VMP, and a plan to perform validation and qualification? Are persons identified with responsibilities for validation? 5 Complaints Reviewed Corrective action Responsible person Counterfeiting. Thorough investigation Other batches Batch records. Review records Competent authorities informed What is the company's approach to cleaning validation and what is the extent of cleaning validation? Is there a comprehensive procedure for handling complaints? 7 Contract production and analysis Defined, agreed and controlled Product license Final approval for release The contract giver Responsibilities Information supplied Specifications The contract accepter GMP compliance Third party The contract Written contract Batch release Licenses Materials Production Quality control Sampling Records Reference samples Rejects Are responsibilities defined for contract manufacture and analysis? Is there a written agreement covering the elements of contract manufacture and analysis? 8 Personnel and training Responsibilities Written descriptions Are there written job descriptions defining 3

5 Authority Unauthorized access Training programme GMP and duties Specific training responsibilities? Do people have authority to execute the work to be done? Can persons cope with the workload? Are people experienced in GMP? Is there a procedure and program for training of personnel, and is it implemented? Does it cover GMP and procedural training (SOPs)? Are people working in special areas such as sterile product manufacturing, receiving specific training? 10 Premises Dust control Electrical supply Rodent and pest control Separation and segregation Temperature Relative humidity Receiving areas Poisons Drains Effective ventilation Packaging areas Production areas How is dust controlled in areas where dust is generated? What precautions are taken to ensure proper electrical supply? Is there an effective rodent and pest control procedure? How are batches of materials/products, and different products separated and segregated? Is temperature (and/or relative humidity) controlled, monitored and recorded where needed? Is the receiving area designed in a proper way to also make provision for cleaning of incoming materials? Is there a suitable air system with proper ventilation and filtration to prevent contamination and cross- 4

6 contamination, ensuring suitable environmental conditions for the products as required? Is the layout, design, finishing and space in production and packaging areas suitable to ensure the production of quality products with no contamination, cross-contamination or mixups? 11 Equipment Validated cleaning Washing, cleaning and drying equipment Laboratory equipment and instruments Are production equipment suitable for processing? Does the manufacturer have validated cleaning procedures for equipment? What measures are taken to ensure that the cleaning and drying procedure does not become the source of contamination? Are laboratory equipment and instruments suitable for testing? 12 Materials Direct contact - suitable grade Containers Starting materials Status Dispensing Packaging materials Obsolete materials Intermediate and bulk products Conditions. Purchasing Finished products Quarantine until final release Release Rejected, recovered, reprocessed and reworked materials Are materials that may come into contact with product (direct or indirectly) of suitable quality and controlled? Are containers suitable for use, cleaned properly, and appropriately labelled? Are damaged containers handled in a suitable manner - checked by QC? How are starting materials controlled (e.g. batch numbers, status)? Is the weighing area suitable and the weighing done in a manner that prevents contamination and crosscontamination? Are the issued materials 5

7 Separate Reworking Recovery Recalled products Stored separately Returned products Written procedure Records Reagents and culture media Records Procedures Positive and negative controls Reference standards Secondary or working standards 13 Documentation Traceability Records Distribution Compliant with licenses. Changes Reproduction Revision Alteration Release and rejection procedures Records of validations, calibrations, maintenance, cleaning, or repair Cleaning and sanitation procedures checked in the packaging area before use? Are the procedures for the handling of intermediate products, finished products, rejected materials, reworks, reprocessing appropriate and followed? Are the procedures and records for reagents and culture media appropriate, implemented and maintained? Is there a procedure (with records) for the preparation, testing and handling of reference materials? Is the procedure for the review, distribution and retrieval of documents appropriate? Are changes to documents controlled? Is there a procedure that is followed for the release and rejection of materials, components and products? Are records maintained (e.g. calibration, maintenance, cleaning). Are SOPs for cleaning in different areas detailed, followed, and validated? 14 Good Practices in Production Environmental monitoring Line clearance Equipment failure Is environmental monitoring performed in accordance with SOPs, and records maintained? Is there a procedure and checklist for line clearance in different areas? Are failures recorded, 6

8 investigated and indicated including support utilities and equipment? 15 Good Practices in Quality Control Sampling Sampling equipment Sample containers Out-of-specification results (OOS) Is the sampling area appropriately designed, and sampling done in a manner that prevents possible contamination, crosscontamination and mix-ups of materials? Is there a procedure for OOS investigation and relevant records? 16 Dosage form specific aspects Tablets, capsules Sterile injections (small volume) 7