English — official text

Annex 1 — Annex 1

ANNEX 1 SITE MASTER FILE REQUIREMENTS GUIDANCE C.1 GENERAL INFORMATION C.1.1 Brief information on the site (including name and address), relation to other sites and, particul arly, any information relevant to the understanding of the GDP operations In not more than 250 words (one A4 page ), outline the company's activities, other sites (if any), in additi on to the site that is t he subject of this report. C.1.2 GDP operations as licensed by the Competent Authorities 1. Indicate whether the site has obta ined approval from any authority in Singapore, or any Competent Authority ov erseas (in the case of the latter, provide the name of t he authority in question and state the scope of approval, indicating if any similariti es or differences exist in this application). 2. Quote the relevant document (licence) as issued by the Competent Authority. State the period of validity of licence document (if the validity of the document is given in the country concerned). Any conditions and/or restrictions should be stated. C.1.3 Any OTHER operations carried out on the site This covers both medical device related and non-medical device related activities. Secondary assembly activities, if performed, are to be specified. MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.1.4 Name and exact address of the site, including telephone and fax numbers 1. Name of company, site address and mailing address (if different from site address) 2. Telephone, fax nos. and ema il address of contact person C.1.5 Type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken 1. Quote the type of medical devices handled, specifying if the medical device is handled under a contractual agreement with a contract giver. 2. Note any toxic, hazardous, highly sensitising substances handled e.g. antibiotics, hormones, cytostatics. Note whether special precautions were taken for such medical devices. (L ist the appropriate licence numbers where applicable) C.1.6 Short description of the site (size, location and immediate environment and other activities on the site) 1. Provide a map indicating the locati on of the site(s) and the surrounding area. Mark the site(s). 2. Other activities on the site, incl uding secondary assembly line, if applicable. C.1.7 Number of employees engaged in administration, warehousing, distribution ,transportation and secondary assembly* (Note: Include employees working only par t-time on full-time equivalent basis. Indicate if activity is outsourced.) 1. Administration 2. Warehousing 3. Distribution 4. Transport 5. Secondary assembly (if applicable) MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.1.8 Use of outside ad ministrative or other technical assistance in relation to the operation (if so, see C.8 for details) For each work process outsourced or sub-contracted (including contract delivery companies), give:- 1. Name, address, telephone no. and fax. no. of contractor 2. Brief outline of the activity being undertaken in not more than 100 words or half an A4 sheet. C.1.9 Short description of the quality management system of the company (Not more than 750 words or three A4 sheets). 1. Describe the elements of the company structur e, responsibilities and procedures. 2. Describe the audit programmes and organisations undertaken. 3. Describe the manage ment review system. 4. Record if the company has been certified to industry standards (e.g. ISO 9000, ISO 13485:2003) MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.2 PERSONNEL C.2.1 Organisation chart showing the arrangements for key personnel Organogram listing key personnel has to be constructed. Record senior managers and supervisors only. C.2.2 Qualifications, experience and responsibilities of key personnel 1. Brief details of academic qualificat ions, work-related qualifications and years of relevant experience sinc e qualifying. Include their names 2. Job descriptions for the key personnel C.2.3 Outline of arra ngements for basic and in-service training and how records are maintained Give brief details of the training programme and include induction and continuous training, as follows:- 1. Describe how training needs are identified and by whom. 2. Give details of traini ng relative to GDP requir ements, including secondary assembly (if applicable) 3. State the form of training e.g. in -house, external, and how practical experience is gained and which staff are involved. 4. Explain how the effectiveness of training is assessed e.g. by questionnaire. 5. Explain how retraining needs are identified. 6. Give brief details of training records kept. MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.3 PREMISES AND FACILITIES C.3.1 Simple layout plan and description of warehousing areas with indication of scale (architectural or engineering drawings not required) Layout of premises 1. Provide a site layout plan highlight ing all warehousing and other functional areas. 2. Describe the controls availa ble to prevent unauthorised access. 3. Provide a simple plan of each area with indication of scale. Label areas and annotate plan with names. 4. Plans should be legible and on A4 sheets. Plans could be on A3 sheets if considered necessary. C.3.2 Brief description of ventilation systems. More details should be given for critical areas providing special storage conditions Brief description of ventilation systems etc. Note 1: More details should be given for critical areas. Note 2: To reduce the narrative, schematic drawings should be used. The following data should be given:- Design criteria e.g.  Specification of the air supply  Temperature  Humidity C.3.3 Special areas for the handling of highly toxic, hazardous and sensitising materials Follow the same layout as above for descr iption of areas specially designated for the handling of highly toxic, hazardous and sensitising materials. MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.3.4 Maintenance (description of planned preventive maintenance programmes and recording system) Maintenance Note: For the purpose of this guide, "maintenance" is carried out by the company and "servicing" is by an outside contractor. 1. Describe the planned preventive maintenance programme. 2. Who is responsible for maintenance and servicing? 3. Are there written procedures and contractual details for outside work? 4. Are there written proc edures and suitable reporting forms for maintenance and servicing? Do the documents record type/frequency of service/checks, details of servic e, repairs and modifications? 5. Have the maintenance routines that could affect medical device quality been clearly identified? 6. Are the reports made known to the users? C.3.5 Availability of written specifications and procedures for cleaning the areas 1. Cleaning procedures for the areas. 2. Are there written procedures for cleaning and specifications for cleaning agents and their concentration for the method of cleaning and the frequency? 3. What are the cleaning methods (and their frequency) for the vehicles? C.3.6 Policy on the storage of medical device 1. How are medical devices of differe nt status (eg quarantine, rejects, approved, etc) segregated and contro lled, e.g. by computer, labels? 2. How are the medical device s stored e.g. pallet racking? 3. Describe any special storage or handl ing conditions such as cold chain management. 4. Describe the pest control programme. MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.4 STOCK HANDLING AND STOCK CONTROL C.4.1 Arrangements and recording system for distribution 1. Description of receiving, hand ling and storage of medical device:- a. Checking of medical devi ces at point of receipt. b. Does the despatch order ensure firs t in first out (FIF O) and identify the lot number? c. What are the methods of distribution to customers? 2. Records of Distribution:- a. Do the retained records permit full batch traceability from the factory to the customer in terms of the date of sale, customer details and quantity despatched? 3. Stocktaking procedure. Include informa tion on how it is being conducted and its frequency. C.4.2 Deliveries and transportation 1. Description of how the security, st orage condition and protection of the quality of medical device are cons idered during transportation. 2. Description of the ve hicle fleet available:- a. Number of vehicles and their capacity b. Is the vehicle dedicated? c. Is the vehicle specially adapted to transport special medical device (e.g. cold items, radioactive substances) d. How is the transport route planne d (e.g. for cold items, radioactive substances)? MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.5 DOCUMENTATION C.5.1 Arrangements for the preparation, revision and distribution of necessary documentation, including storage of master documents This section refers to all documenta tion used in GDPMDS activities. Arrangement for the preparation, revision and distribution of documentation:- 1. Is there a description of the documentation system? 2. Who is responsible for the prepara tion, revision and distribution of documents? 3. Where are the mast er documents stored? 4. Is there a standard format and inst ruction of how documents are to be prepared? 5. How is the docum entation controlled? 6. For how long are the documents kept? 7. Detail any arrangement for electr onic or microfilmed records. MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.6 MEDICAL DEVICE COMPLAINTS AND FIELD SAFETY CORRECTIVE ACTION C.6.1 Arrangements for the handling of complaints Complaints 1. Is there a writt en procedure for medical device complaints? 2. Who is responsible for:- a. Logging; b. Classifying; c. Investigating complaints. 3. Are written r eports prepared? 4. Who reviews these reports? 5. For how long are complaint records kept? C.6.2 Arrangements for the handling of field safety corrective action Field safety corrective actions 1. Is there a written pr ocedure which describes the sequence of actions to follow including:- a. Retrieval of di stribution data; b. Notification of customers; c. Receipt/segregation/inspection of returned medical devices; d. Investigation/r eporting of cause. e. Reporting corrective action. 2. Who is responsible for coordinating medical device field safety corrective actions? 3. Who notifies the Competent Authority of field safety corrective actions? 4. Can field safety corrective actions be effected below wholesale level? MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.7 INTERNAL AUDITS C.7.1 Short Description of the internal audit system 1. Describe how the internal audit system verifies that those activities that have a bearing on medical device qu ality comply with the planned arrangement. 2. Are there documented procedures fo r the internal audit system and for the follow-up actions? 3. Are the results of the internal audit documented, brought to the attention of the personnel having responsibi lity for the area and activities inspected? 4. Does the system ensure that those responsible for the area or activity take timely corrective acti on on the deficiencies found? MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.8 CONTRACT ACTIVITIES C.8.1 Description of the way in which the compliance of the contract acceptor is assessed Describe briefly the details of the tech nical contract between the contract giver and acceptor and the way in which the GDP compliance, or compliance with other appropriate standar ds, is assessed. The selected standards should be assessed for the suitabil ity of its application. The type of activities undertaken by the contract accept or should be specified. MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.9 SECONDARY ASSEMBLY (if applicable) C.9.1 Description of the secondary assembly process 1. Information describing t he medical devices that are to be repackaged, the equipment used in the assembly activities. 2. List of applicable work instructions and operational procedures for secondary assembly, including details of operational conditions and processes for the labeling and packaging. C.9.2 Description of the documentation process for traceability 1. Description of the documentation system for batch assembly records? 2. Who is responsible for verifying and approving the batch assembly records? 3. Is there a standard format and inst ruction of how documents are to be prepared? 4. How is the documentation controlled? 5. For how long are the batch assembly records retained? 6. Does the batch assembly record identify the amount assembled and approved for distribution? C.9.3 Description of th e materials control established 1. Prior to repackaging, a. Are the incoming medical devices checked for integrity of package and seal? b. Are the incoming medical devices appropriately labeled? c. (If applicable) are the special st orage conditions for the incoming medical devices adhered to? 2. Are the packaging materials appr opriately purchased, handled and controlled? 3. Do the repackaged medical device s bear all the original labeling information (including instructions for use, label and any other informational sheet or leaflet, etc.)? MEDICAL DEVICE GUIDANCE JUNE 2011 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP C.9.4 Description of the good assembly practice Written procedures for the following, if performed:- 1. Assembly operation 2. Printing operations 3. Cleaning and maintenance of assembly equipment 4. Calibration of assembly equipment C.9.5 Description of quality control implemented Written procedures for finished medica l device assessment, including:- 1. Review of packaging documentation, 2. Compliance with finished medical devi ce specification and examination of finished product. Contact Information: Medical Device Branch Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg T: 6866 3560 F: 6478 9028