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Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility:
1.General information
(a) name of establishment inspected
(b) date of inspection
(c) name(s) of the inspector(s)
(d) date of last inspection.
2.Type of inspection
Comprehensive, concise, follow-up, special, investigative, announced, and unannounced.
3.Licensing
(a) licensing of premises
(b) person with supervisory role in establishments
(c) adherence to licensing provisions.
4. Activities undertaken on premises
manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes.
5. Adequacy and suitability of premises
(a) premises clean, tidy and in good state of repair
(b) premises secure
(c) floor durable and easily cleaned
(d) premises constructed to prevent infestation by vermin and pests
(e) changing rooms and toilet available
(f) adequacy of lighting and ventilation
(g) appropriate layout of premises.
6. Warehouse/store
(a) adequacy and suitability of warehouse/store
(b) warehouse/store clean and uncluttered
(c) warehouse/store inaccessible to unauthorized persons
(d) temperature and humidity control
(e) enforcement of stock rotation
(f) adequacy of shelving
(g) existence of areas for returned, recalled, quarantined or expired products
(h) warehouse/store free from vermin and insects.
7. Special storage
(a) availability of cold room storage or refrigerator for vaccines and
biological products
(b) suitability of the cold storage facilities
(c) standard written procedure prepared by an appropriate national
regulatory agency for the maintenance of cold chain
(d) special storage area for controlled drugs and other prescription drugs
(e) suitable and secure storage facility for controlled drugs and poisons.
8. Record-keeping
(a) name and address of supplier of each product with date
(b) name and address of purchaser of each product with date
(c) supplier or purchaser license
(d) retention of order forms, copy of delivery notes, stores receipt, and issue vouchers, and book of records (controlled drugs book/prescription drugs book) on the premises as provided for in the drug laws
(e) accuracy of records kept.
9. Conditions for sale and supply
(a) sale and supply of product under the control of an authorized personnel
(b) sale and supply of product from registered/licensed premises
(c) sale of prescription (drugs) on the basis of valid prescription
10. Diversion of controlled products
Diversion of controlled products prevented by examining the records and by physical examination of stock.
11. Returned and expired products
Procedures in place for handling returned and time-expired products.
12. Product recalls
Procedures in place for recall of products and handling recalled products.
13. Product complaints
Procedures in place for dealing with complaints about products.
14. Promotional activities
Assess promotional materials for compliance with laws.
15. Personnel
(a) person responsible for supervising sale in a wholesale/retail pharmacy is a registered/licensed pharmacist
(b) name of the personnel
(c) personnel wears clean protective clothing.
16. Labeling of products and package inserts
Check adequacy of labeling of products and information on package inserts.
17. Physical examination and sampling of products
Conduct physical examination of products in stock and take samples for quality assessment.
18. Reference books
Check existence of reference books on premises, where they are required.
19. Guidance on sampling
(a) Check that the sample is properly labeled with the following:
(I) name of sampled pharmaceutical preparation
(II) batch number
(III) date and source of sample; the original manufacturer's label may be helpful.
(b) Check that the records contain the following:
(I) number of samples
(II) types of packaging and storage conditions
(III) circumstances of sampling that may include suspected quality defects.
(c) Place seals on containers of the samples.
(d) Hand over one-third of the samples to the representative of the inspected establishment.
(e) Confirm in writing that samples were taken from the premises and have the confirmation countersigned by an appropriate official of the inspected establishment.
Overall it is the management's objective to manufacture the product as per the specifications and guidelines.
Records Maintenance for Equipments in Use
Records of major equipment use, cleaning, sanitization, maintenance etc should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.
Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility:
1.General information
(a) name of establishment inspected
(b) date of inspection
(c) name(s) of the inspector(s)
(d) date of last inspection.
2.Type of inspection
Comprehensive, concise, follow-up, special, investigative, announced, and unannounced.
3.Licensing
(a) licensing of premises
(b) person with supervisory role in establishments
(c) adherence to licensing provisions.
4. Activities undertaken on premises
manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes.
5. Adequacy and suitability of premises
(a) premises clean, tidy and in good state of repair
(b) premises secure
(c) floor durable and easily cleaned
(d) premises constructed to prevent infestation by vermin and pests
(e) changing rooms and toilet available
(f) adequacy of lighting and ventilation
(g) appropriate layout of premises.
6. Warehouse/store
(a) adequacy and suitability of warehouse/store
(b) warehouse/store clean and uncluttered
(c) warehouse/store inaccessible to unauthorized persons
(d) temperature and humidity control
(e) enforcement of stock rotation
(f) adequacy of shelving
(g) existence of areas for returned, recalled, quarantined or expired products
(h) warehouse/store free from vermin and insects.
7. Special storage
(a) availability of cold room storage or refrigerator for vaccines and
biological products
(b) suitability of the cold storage facilities
(c) standard written procedure prepared by an appropriate national
regulatory agency for the maintenance of cold chain
(d) special storage area for controlled drugs and other prescription drugs
(e) suitable and secure storage facility for controlled drugs and poisons.
8. Record-keeping
(a) name and address of supplier of each product with date
(b) name and address of purchaser of each product with date
(c) supplier or purchaser license
(d) retention of order forms, copy of delivery notes, stores receipt, and issue vouchers, and book of records (controlled drugs book/prescription drugs book) on the premises as provided for in the drug laws
(e) accuracy of records kept.
9. Conditions for sale and supply
(a) sale and supply of product under the control of an authorized personnel
(b) sale and supply of product from registered/licensed premises
(c) sale of prescription (drugs) on the basis of valid prescription
10. Diversion of controlled products
Diversion of controlled products prevented by examining the records and by physical examination of stock.
11. Returned and expired products
Procedures in place for handling returned and time-expired products.
12. Product recalls
Procedures in place for recall of products and handling recalled products.
13. Product complaints
Procedures in place for dealing with complaints about products.
14. Promotional activities
Assess promotional materials for compliance with laws.
15. Personnel
(a) person responsible for supervising sale in a wholesale/retail pharmacy is a registered/licensed pharmacist
(b) name of the personnel
(c) personnel wears clean protective clothing.
16. Labeling of products and package inserts
Check adequacy of labeling of products and information on package inserts.
17. Physical examination and sampling of products
Conduct physical examination of products in stock and take samples for quality assessment.
18. Reference books
Check existence of reference books on premises, where they are required.
19. Guidance on sampling
(a) Check that the sample is properly labeled with the following:
(I) name of sampled pharmaceutical preparation
(II) batch number
(III) date and source of sample; the original manufacturer's label may be helpful.
(b) Check that the records contain the following:
(I) number of samples
(II) types of packaging and storage conditions
(III) circumstances of sampling that may include suspected quality defects.
(c) Place seals on containers of the samples.
(d) Hand over one-third of the samples to the representative of the inspected establishment.
(e) Confirm in writing that samples were taken from the premises and have the confirmation countersigned by an appropriate official of the inspected establishment.
Overall it is the management's objective to manufacture the product as per the specifications and guidelines.
Records Maintenance for Equipments in Use
Records of major equipment use, cleaning, sanitization, maintenance etc should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.
thank you for sharing with us your knowledge. it's the first time i heard about this checklist, i will use it to improve the quality assurance.
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