(v) Are all sections adequately staffed (Supervisor / Asst. analyst) taking in to
Consideration the workload? YES
(vi) Is recruitment of an employee preceded by medical examinations? YES (before joining) Refer Annexure 5 of GMP Manual
Procedure for medical check-up of employees.
(vii) What is the periodicity of subsequent medical examinations?
Once every year, Refer Annexure-5 of GMP Manual- procedure for medical checks up of employees.
(viii) Is an employee whose state of health is doubtful immediately removed from work site until he is fully recovered and Medical Fitness Certificate submitted? YES, Refer Annexure-6 for personal hygiene and cleanliness.
(ix) Do all personnel receive GMP's training? (Check course content of training). YES, Refer Annexure 7 of GMP Manual (Training Records are available).
(x) Is training documented? YES Records are available.
(xi) What is the periodicity of training?
As per the training schedule and also as and when required.
(xii) Are protective steps against likely damage to health due to occupational hazards satisfactory? YES,
(xiii) Are steps against likely damage to health due to occupational hazards satisfactory? YES, Facilities provided are adequate.
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| 3. (i) (ii) (ii-a) (iii) (iv) (iv-a) (v) (vi) (vii) (viii) (ix) (x) (xi) | PREMISES Are there are source of pollution in the neighborhood of the building? Is plant layout of suitable size design & construction sufficient for production and Quality Assurance of medical device being produced? Any open drain, blocked sewer or public lavatory nearby? Is there adequate space for equipment, material and movement of personnel and material? Is there any programme to check entry of birds, rodents and insects? Are any products other than Medical Devices being manufactured in the same building? Are buildings and facilities properly constructed to facilitate adequate cleaning and sanitization? Are lighting and Ventilation adequate? Are facilities for changing street clothes, footwear, washing and toilets adequate and satisfactorily maintained? Are sewage, trash and other effluent disposal adequate? State of maintenance of building (Check whether the firm/company have preventive maintenance programme) Are floors, walls and ceiling properly constructed and easy to clean, maintain and disinfect? Is there any programme for general housekeeping? | N Y N Y Y N Y Y Y Y Y Y Y | Annexure 8 Annexure: 9 Annexure-12 Annexure-10 Annexure-11 Annexure -12 Annexure-12 |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| 4. (i) (ii) (iii) (iv) (v) (v-a) (v-b) (vi) (vii) (viii) (ix) (x) (xi) (xii) (xiii) | STORAGE OF STARTING MATERIALS Are there physically segregated areas for - Receiving materials? - Packaging materials? Is there quarantine area for incoming raw material? Is there segregated area for rejected material? Are there separate areas for material requiring special storage conditions e.g., - Controlled temperature? - Flame proof? Are the areas adequate for storage of the materials in relation to their amount and facilities provided? Do all containers of active RMs expedients and intermediates bear appropriate labels at all stages of manufacture? If no, give details Are empty containers freed of old labels and checked immediately prior to use? Is lighting and ventilation adequate in warehouse? Have the areas requiring special storage conditions provided with monitoring devices and data maintained? Is there any programme for general housekeeping? Is there any evidence of entry of insects, rodents & birds? Are there warehousing operating instructions? Are these instructions being followed? Are there labels for materials of different status i.e., quarantine, tested and released for accepted and rejected? Are there labels of different colours? | Y Y Y Y Y Y Y N Y Y Y N Y Y Y Y | Reject material is kept in defined area The inflammable material is kept in defined locations Appropriate labels are put on the RM and WIP Empty containers are destroyed Annexure-12 Annexure-13 Do System of Labeling adequate The labels are prominent and of different color that can be identified by anybody |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (xii-a) (xiv) (xv) (xvi) (xvii) (xviii) (xix) (xx) (xxi) (xxii) (xxiii) | Are labels on containers of RMs to be used in manufacture checked with regards to identity, quantity, & QA approval? If no, give details. Are there the following information on labels? - name of material? - Serial number? - Analysis number? - Date of accepted/ rejected? - Date of testing? - Date of expiry? Is the testing performed by Qualities Assurance personnel? Are there sampling procedures? Are there the following information of each sample taken? - Name of person who performed sampling? - Number of samples taken? - Number of containers sampled - Date of sampling? Are the containers provided for storage of raw materials suitable to preserve the quality? Is there stock rotation programme (i.e., FIFO)? Are the printed packaging material stored in orderly manner and well separated to prevent mixing? Are they recorded on stock cards/registers? Are enclosed and locked areas provided for storage of highly flammable? Is exterior storage available: - Solvent storage area? - Inflammable material storage area? - Whether safety measures provided have been assessed by regulatory agency if any? - Are SOP’s available for handling of these materials? | Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y | QA Approval
the containers Annexure-14 Quality Plan -----do------ Refer in-coming inspection report FIFO system is implemented Refer stock register for labels MSDS AVAILABLE |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (vi) (vii) (viii) 7 (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) (x) | Are logbooks maintained for cleaning, maintenance and sanitization of major equipment? Are SOPs readily available to operators? If automatic electronic or mechanical equipment is used, are there? - Written programmes for calibration/ inspection. - Records of such programmes? - Checks to ensure that any changes are made only by authorised person? FACILITIES AND UTILITIES Is air handling units adequate and properly located and functional? Is air conditioning system adequate and functional? Are steam generation facilities adequate and functional? Are vacuum system adequate and functional? Is compressed air system adequate and properly functioning? Is water supply system adequate? Check whether MCD or Tube well supply. If tube well supply, whether potable? Is distilled water qualities and supply system adequate? Is demineralised water quality & supply system adequate? Sanctioned power 1000 KVA Generator 500 KVA (2 No.s) are provided | Y Y Y Y Y Y Y Y Y NA NA Y Y | Refer Preventive log books and records Available to maintenance in-charge Refer Calibration records
Tube well is Used. Potable water Test Reports available |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| 7-A (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) 8. (i) (ii) (iii) (iv) (v) | SANITATION AND HYGIENE Are cleaning schedule available for: - Floors? - Walls? - Ceiling? - Doors & windows? - Electrical fittings? -Machines For different sections. Are SOPs available for cleaning & sanitization? Are disinfectants used rotated? Is microbial load monitored in different sections? Is microbial load monitored in different sections? Are adequate facilities available for personal hygiene before entering into production area? Are personnel instructed to observe personal hygiene? Are clean protective clothing provided to personnel? Are clean sterile protective clothing changed every time a person enters sterile area? PRODUCTION AND IN-PROCESS CONTROL Is there master production document for each medical devices being produced? Are alterations to processes recorded and authenticated by competent authorized persons? Is the addition of components verified by another person? Is an appropriate in-process control being performed? Is there faculty to test the Sterile product? | Y Y Y Y Y Y Y Y NA Y Y Y Y Y | Cleaning Logs for different sections Annexure -12 Annexure-6 Annexure-4, Bill of material records Manufacturing Head is authorized |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (vi) (vii) (viii) (ix) (ix-a) (x) (xi) (xi-a) (xi-b) (xii) (xiii) | Are adequate measures taken to prevent cross contamination during production of different products in the same facility? If drying ovens are used: - whether one product is dried at one time? Are instrument used for temperature, pressure or other recording calibrated periodically and records maintained. Are semi finished products stored properly and are identified? Is stage of manufacture clearly indicated on containers? Is quality of water monitored? The following points may be checked? - source of water? - Is it potable? - In case de-ionized water source of feed water? - Frequency of charging columns sampling frequency? - In case of water for injection information like: - Is it prepared by distillation or reserve osmosis? - Whether storage temperature is maintained at not less than 800C and circulated? Do the containers and closures meet required specification? Are containers checked for cleanliness and suitability for packaging before use? Are containers of intermediates, FPs intended for use in the plant closed properly? Is homogeneity maintained during filling of ointment, creams and lotions? Are the following controls carried out during filling operations: - Checks of column, weight or counts? - Visual inspection of empty and filled containers? - Visual inspection of closures? | Y N.A Y Y Y Y Ground Water Y NA NA NA NA NA Y Y Y NA NA | Refer calibration records Stored at the work place where it is being manufactured Appropriate labels are put Reports are available Refer water test records from independent lab. |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (xiv) (xv) (xvi) (xvii) (xviii) (xix) (xx) (xxi) (xxii) (xxiii) (xxiv) (xxv) (xxvi) | Is there adequate separation of packaging lines to prevent mix-ups? Is each line identified with name of the product, serial no. and packaging size? Is there only one serial of product on packaging line at any given time? Is an inspection carried out of each packaging line before labeling and packaging operation? Is the inspection verified by quality control? Is significant discrepancy in actual yield investigated? Is inspection carried out of each packaging line after operation to ensure that all excess/rejected labeling material are removed? Are all excess or rejected coded labels and cartons destroyed? Is serial production record prepared for each serial of product and maintained? Do the serial production records indicate that each significant step in manufacturing was performed and checked by second individual wherever appropriate? Are master instruction or procedures being followed? Are these instruction and procedures being followed? Are only materials, containers and appliances necessary for the job in hand stored in the vicinity of the manufacturing areas and are these properly labeled with name of the product, serial no. date, etc. | Y Y Y Y Y NA Y Y Y Y Y Y Y | One lot/batch is packed at a time as the packing is done simultaneously with assembly and is automated. Line clearance is maintained. The rejected and unused labels are returned to the stores. Do BPR available Refer the BPR -DO- Refer Insp. Reports Refer Master Inst./ Procedure The containers are labeled appropriately for the work status |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (iv) (v) (vi) (vii) (viii) (ix) (x) (xi) (xii) (xiii) (xiv) (xv) (xvi) | Are there procedures and specifications for acceptance of reprocesses material? Are there written sampling procedures for: - raw materials? - Packaging and labeling materials? - Finished products? Are samples collected by QA personnel? Is there special room for microbiological and sterility testing? Is the environment of room controlled? Cultures, Sub cultures: - Are microbial strains obtained from Authorized / reputed source? - Frequency of Sub-culturing. - frequency of identification of organism by microscopically or biochemical test - Are records of sub culturing and identification of strain maintained Are animal test performed? Are animal properly housed? Are all raw materials, containers, closures, and labels and printed packaging materials approved and released by QA for use in manufacture of Equipment? Is in-process controls carried out by QA personnel? Are semi-finished products tested for appropriate tests when necessary? Are bulk finished products tested for established specifications before packing? Is every finished product tested for established specifications before release for sale? | Y Y Y Y Y Y Y Y Y Y NA Y Y Y Y Y | Refer SOP for Reprocess Material Refer QUALITY PLAN MICROBIOLOGICAL LAB IS ESTABLISHED. Test to be done from external Lab Every Do Test to be done from external Lab Refer BPR As per the quality plan |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (xvii) (xviii) (xix) (xx) (xxi) (xxii) | Is there any deviation from established procedures or specifications and are these justified? Does the QA maintain records of the entire test carried out? Does the QA review all production and control records to ensure compliance with established written procedures before a serial of the products is released for sale? Reference Standards: (a) Are reference standards (R.S.) available? (b) Are these primary or working R.S.? (c) Are working RS calibrated against primary R.S> or C.R.S.? (d) Are R.S. stored properly ( at low temperature under dehumidified conditions)? (e) Are records of R.S. and their calibration maintained? Are samples in sufficient quantity for testing twice retained of starting materials and finished products for future examination, in case of need? Is written programme available for stability studies including the following: - Sample storage condition? - Room temperature? - Accelerated ageing test? - Sample size and test intervals? - Reliable and specific test methods? - Testing in the same containers closure system in which it is marketed? - Date and expiration date? | N Y Y NA Y Y Y Y NA Y Y Y Y | Refer to inspection reports Refer to Batch history/master device record. Refer to Batch history/master device record. The master devices kept, verified. |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| 11. (i) (ii) (iii) (iv) (v) (vi) (vii) 12. (i) (ii) (iii) (iv) (v) (vi) | STORAGE OF FINISHED PRODUCTS Is the area adequate with reference to materials stored? Are lighting and ventilation adequate? Whether special areas with temperature and humidity control required? Have these been provided? Is there stock rotation programme (FIFO)? Are there inventory records to show: - Amounts? - Serial number? - Date of receipt? Have distribution records been maintained? Do distribution records provide sufficient information for product recall purpose? Is there segregated area for retrieved goods? Are records available for retrieved goods? DOCUMENTATION Are SOPs available for the following: - Receipt of raw materials and other components? - Quarantine and storage? - Quality control system and approval/rejection? - Release to production? - Weighing and dispensing? - Processing and production operations? - Packaging and labeling? - Quality control? - In-process? - Finished products? - Storage of finished products? - Distribution? - Returned goods? - Recalls and complaints? - Cleaning and maintenance? - Quality control of water? - For reworking of nonconforming serials in existence? If yes, check records. Have these SOPs been prepared, signed and dated by responsible person? Are there additional documents like log books, notebooks or other similar records available to show execution of various functions? In case of review and changes, are SOPs signed by responsible person and do these show their date of effectiveness? Are there records of receipt of raw materials and do these have following information? ( Material Receipt Note-MRN) - receiving MRN document number? - Date of receipt ? - Supplier? - Manufacturer? - Manufacturer’s serial number? - Type and size of containers? - Number of containers and conditions? Are there records of stock and issue of raw material and do these have following information: - Opening balance? - Date of receipt - Quantity received? - Name and serial number assigned by the manufacturer (if any)? - Invoice number, date, name and address of supplier? | Y Y NA Y Y Y Y Y Y Y Y N Y Y Y Y NA Y Y Y Y Y Y Y Y Y Y Y NA Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y | Stock Ledger- Maintained Master device records verified Batch history record/master device records verified Invoices and Master device records have customer add. Qty. etc. No such case Reported till date Refer Quality Plan SOP for material release to production. Refer SOP SOP for Labeling & Packaging Refer Quality Reffer SOP for Material Handling & storage Product recall procedure -DO- Refer SOP for sanitation and Cleaning, Log books, Preventive MNT Schedule (No nonconforming serials in existence) Refer procedure for document control Refer procedure for document control The work instruction issue and revision status verified MRN and stock register verified Stock register verified |
| S.NO. | CATEGORIES | COMPLIANCE Y/N/NA | REMARK/ COMMENTS |
| (vii) (viii) | - Analysis report number and date? - Date of expiry - Date of issue? - Name and serial number of product for manufacture of which issued? - Balance? - Signature of issuing persons? Is there master formulation records for each device product being produced? Is there a separate master production documents for each dosage form/ serial size? | Y NA Y Y Y Y Y Y | Refer Bill of material records BPR available DO |
| (ix) (x) (xi) (xii) (xiii) (xiv) | Is a production record prepared for every equipment produced? Is it reproduction of the appropriate master production documents or it has all critical information about the serial. Has it been checked for accuracy signed and dated by a responsible person? Are the records maintained by QA for all the test carried out? Do these records include: - graphs, chart, spectra, etc? - calculations? - Signatures of individuals who performed the test? - Signatures of the designated person responsible for the review of records for accuracy and compliance with established standards? Are other associated records available? | Y Y Y Y NA NA Y Y Y | Refer record for every equipment produced -DO- |
| (xv) (xvi) (xvii) 13. (i) (ii) (iii) (iv) (v) (vi) (vii) Note: 14. (i) (ii) | Is documentation available readily for examination? Where errors have been made in entering or transcribing data: - have errors been crossed out with one line? - Have corrections been made above those crossed out? - Are corrections dated and initialed? Are serial production records capable of giving complete history of the serial right from the RM stage to the distribution of FP? CALIBRATION OF INSTRUMENTS AND MEASUREMENT SYSTEMS Are the balances calibrated routinely? Have measuring equipments been calibrated? Have thermometers/thermocouples been calibrated? (temperature at which calibrated- Minimum- Maximum- Have the pressure gauges been calibrated? Are instruments routinely calibrated? What is the periodicity of calibration? Are records maintained for all calibration? Draw a list of all majors instruments available and check calibration records? VALIDATION AND REVALIDATION Are validation studies carried out for the following: - cleaning and sanitation procedures? - Process? - Testing? Have qualification studies been carried out for equipment before validation studies? | Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y | Serial Movement Record available Refer Calibration records Refer to calibration schedule Process validation of moulding, clean room, ETO sterilization is carried out. |
| (iii) (iv) (v) (vi) Note: 15 (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) 16. (i) (ii) | Are validation protocols available for validation studies? Do the validation reports show recorded results and conclusions? Are validation studies carried out periodically? Is revalidation carried out in event of significant change in material (s) or equipment? Check a few qualification and validation studies in details: COMPLAINTS Are there written procedures for handling complaints? Is an investigation carried out wherever necessary including discussion with manufacturing personnel? Are complaints reviewed by QA? Is there a designated person for overall evaluation? Are records maintained for complaints and do these include the following: - Name of the product? - Serial number? - Name of complainant? - Nature of complaint? - Preventive action Is a report of investigation made? Are complaints involving adverse reactions evaluated by qualified personnel? In case of significant adverse reaction, are appropriate Health Authorities notified? PRODUCT RECALLS Is there written procedure for product recall in case of products known or suspected to be defective? Is there a designated person responsible for execution and coordination of product recalls? | Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y | Refer to the process validation records There is procedure for Revalidation Annex-16 procedure for market surveillance Procedure for control of non-conforming product Procedure for preventive action Procedure for preventive action QA Head & Manufacturing Head Refer Complaint Records Refer to product recall procedure No such case occurred |
| (iii) (iv) (v) (vi) (vii) (viii) 17. (i) (ii) (iii) (iv) | Have the degrees of recall been specified (i.e., Degree I, degree II and Degree III) Is the following information available? - Fax, telex, telephone number and addresses of national, regional and local regulatory authorities? - Fax, telex, telephone number and addresses of radio, television and press agencies? - Fax, telex, telephone number and addresses of distributors, wholesalers, hospitals, etc.? - Fax, telex and telephone numbers and addresses of competent authorities of the countries to which the drug products are exported? Is there a system so that distribution records are readily available to the designated person responsible for product records? Is the progress of product recalls recorded and final report issued including reconciliation between the delivered and recovered quantities of the product? Is the effectiveness of product recall evaluated from time to time? Is there a segregated area for recalled product? RETURNED AND SALVAGED DEVICE PRODUCTS Are written procedures available for receipt and control of returned products? If a reason for returning the product implicates other serials is an investigation made and reports prepared? Are returned or salvaged device products destroyed unless QC determines their reprocessing? Are records of returned products maintained including their disposition? | Y Y Y Y Y Y Y Y Y Y Y Y Y | No such instance reported BPR available and verified -DO- No instance reported till date retrieved goods area procedure for control of non-conforming product No such instance Reported till date Procedure Available Product Recall Register |
| (v) 18. (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) (x) 19. (i) (ii) (iii) | Are there written procedures for reprocessing and do these include. - Specifications and characteristics for approval? - Identification of serial to reflect reprocessing? - Revised stability data, if necessary. SAFETY Is a safety manual available? Are safety equipments like helmets, shoes, goggles, etc. available in the factory? Is adequate first aid equipment available at convenient place in the factory Is periodic first-aid training given to staff? Are electrical connections, wiring etc. checked regularly? Is flame- proof equipment used where flammable solvents or materials are stored or handled during manufacture? Is adequate fire fighting equipment like fire extinguishers, ladders, fire buckets filled with water/ sand, etc., available? Are staff trained in fire fighting operation? Is the building safe and provided with emergency exit, escape routes ladders, etc? Does the firm maintain accident history/record? If yes, comment on its adequacy. POLLUTION CONTROL Are arrangements for the following adequate? Disposal of solid/semi-solid waste? Disposal of sewage? | Y Y Y Y Y Y Y Y Y Y Y Y | Procedure of control of non-conforming product Available Centrally. By maintenance Department Fire Extinguishers available and installed List of Trained Personnel attached No accident reported till date Annexure-11 |
| (iv) 20. (i) (ii) (iii) | Disposal of liquid laboratory waste? RESULTS OF PREVIOUS SELF INSPECTION AND CORRECTIVE MEASURES TAKEN Is the report of previous self-inspection available? Recommendations of previous self-inspection? Whether corrective measures have been taken as recommended by previous self-inspection team? | Y Y Y Y | Procedure for internal audit Procedure for improvement |
No comments:
Post a Comment