DOCUMENTATION -- CoA & SPECIFICATIONS

1. DOCUMENTATION: SPECIFICATIONS & CERTIFICATE OF ANALYSIS (COA) HARSHAVARDHAN V KONDHARE SEM II DEPT. OF DRUG REGULATORY AFFAIRS GUIDED BY : Mrs PREETI K TAMANE POONA COLLEGE OF PHARMACY 15-2-2015 SEM II DRA III UNIT III DOCUMENTATION

2. 2

3. 3 SPECIFICATIONS

4. Specifications A document describing in detail the requirements with which the product obtained during manufacture have to conform. A document specification contains several parts : A description of the audience (s) for the document; A detailed outline giving the structure and contents of the document; A work plan showing who is responsible for each part of the document; What the deadlines are for completing each task. 4

5. Specifications: Purpose Three purposes for document specifications: In the workplace, formal document specifications serve three important functions: Economy of effort, Work planning, Writing organization. 5

6. Specifications: Scope T hey should be included for- raw materials and packaging materials product containers and closures . in-process and bulk products finished products preparation of containers and closures For raw materials and packaging materials – should include D esignated name and internal code reference ; R eference , if any, to a pharmacopoeial monograph ; Q ualitative and quantitative requirements with acceptance limits ; 6

7. Specifications: Scope N ame and address of manufacturer or supplier and original manufacturer of the material; S pecimen of printed material ; Directions for sampling and testing or reference to procedures; S torage conditions; Maximum period of storage before re-testing . For product containers and closures C omply with the pharmacopoeial requirements. Validated specifications and procedures should be strictly followed to avoid any effect on quality of product. 7

8. Specifications: Scope W ritten schedule of cleaning shall be laid down and followed for bottles . For in-process and bulk products Authenticated specification must be present. For finished products – should include D esignated name of the product and the code reference ; F ormula or a reference to the formula and the pharmacopoeial reference ; Directions for sampling and testing or a reference to procedures ; Dosage form and package details ; Qualitative and quantitative requirements , with the acceptance limits for release ; 8

9. Specifications: Scope Storage conditions and precautions , Shelf-life . For preparation of containers and closures Schedule × include requirements of machinery, equipment and premises required for preparation of containers and closures. Specifications can be as per the requirement of the manufacturer. 9

10. Document Name Retention Time Responsible Person Specifications 7 Years Technical Service Manager Raw Material Specification 13 Years from the date of receipt Laboratory Manager Finished Product Specifications 13 Years from the date of production Laboratory Manager Packaging Material Specification 7 Years Laboratory Manager 10

11. 11 CERTIFICATE OF ANALYSIS (COA)

12. Certificate of Analysis Certificate of Analysis is a document issued by Quality Assurance that confirms that a regulated product meets its product specification . They commonly contain the actual results obtained from testing performed as part of quality control of an individual batch of a product . S hould be prepared and issued by the company responsible for the material . 12

13. Certificate of Analysis: Purpose and Scope Purpose is to report analytical results for a specific batch of- Raw materials Component API Finished product Other similar item. 13

14. Certificate of Analysis : Contents COA should be approved by an appropriate representative from the testing site & contain : Vendor or supplier information Product information (name and strength) Results for the specific batch, with name of test acceptance criteria and result for each test. Conformance statement Reference to method and specification document Reference of data source Approval and date Expiration date or retest information. 14

15. Certificate of Analysis: Contents Information needed for COA : Name and unique batch number Manufacturer Manufacturing date Retest date Expiry date Transport instruction Storage condition Content of reference substance Note on calculation of the contents Special remark on handling requirement if any All the required tests with their specifications and results. 15

16. Certificate of Analysis: eCOA Certificates of Analysis issued from computer systems without a handwritten signature are common and are acceptable provided the appropriate controls are in-place . The following considerations should be met: Access to the computer system , entering and editing of data should be limited to authorized personnel. Authentication by username and password . Confirmation of the integrity and accuracy should be completed during implementation and then periodically checked thereafter. Data entered into a computer system from which information is extracted for a COA and changes made thereafter should be accompanied by time- and date-stamped audit trails . With these criteria met, the issuance of electronically generated COAs is acceptable provided the COA includes contact information . 16

17. Certificate of Analysis : Some Examples 17

18. 18 REFERENCES

19. 19 THE DRUGS AND COSMETICS ACT, 1940 ( As amended up to the 30th June, 2005) and THE DRUGS AND COSMETICS RULES, 1945 (As amended up to the 30th June, 2005 ), SCHEDULE M, 17. Specification, 22.5 Records of Analysis . Dan Creinin , Certificates of Analysis Confirm Control, February 1, 2005 www.pharmout.net White Paper, How to Implement Good Documentation Practices, Version 01, 2013. www.drugregulations.org/ documentation in pharmaceutical industry. http:// www.sigmaaldrich.com/united-kingdom/technical-services/c-of-a.html#sthash.vFEeMLDB.dpuf www.csv-qa.com/ computer system validation/audit trials

20. 20