Documentation, Premises, Equipment, Qualification, and Validation- Industrial Pharmacy-II

Documentation, Premises Equipment Qualification and validation topics are covered in this presentation. I hope You get your all answers.

1. Name- Ahirrao Sanket Ravindra (Final year B. Pharmacy) Topic- Documentation, Premises and Equipment , Qualification and validation Guidance by- Prof. Vaidehi Patil Mam (Assistant Professor) Department of Pharmaceutics OBVS’s Prof. Ravindra Nikam College of Pharmacy Gondur , Dhule 424002 (MH) 1

2. Documentation : Technology transfer documentation contains information regarding technology transfer for transferring and transferred parties. Each and every step performed from R&D to production, task assignments and responsibilities should be documented carefully. The quality assurance department is responsible for examining and approving the documents related to technology transfer processes. 2

3. The reports involved are: Development Report : To have documented evidence is one of the crucial goals for successful technology transfer. The R&D department is incharge of the documentation of R&D report (a type of technical development file). This file describes the basis for the quality design of drug substances, drug specifications, and test methods. The development report needs to be examined properly for its approval. 3

4. Information included in the development report is listed below: i ) Data involved in pharmaceutical development of new drug substances. ii) Drugs produced at different stages from early development phase to final application of approval. iii) Information regarding raw materials and components used in drug development process. iv) Reason behind different dosage forms, formula designs, and design of different manufacturing methods. 4

5. v) New changes employed in al ready existing processes and control parameters vi) Information regarding stability profile. vii) Specifications and test methods for drug substances, intermediates, drug products, raw materials, and components, along with valid requirement range of important tests like contents impurities and dissolution. viii) Reason behind the selection of test methods, reagents, and columns. ix) Traceability of raw data. 5

6. 2) Technology Transfer Plan : It is useful in defining items and contents of technology to be transferred, and compl e te procedures of individual transfer and transfer schedules. It also establishes judgement criteria for transfer completion. The transferring party is responsible for organising plan before the execution of transfer process The transferring party should finalise an agreement on its contents with the transferred party. 6

7. 3) Report: After the completion of technology transfer, a report is made by selecting data as per the technology plan and ensuring whether or not the predetermined judgement criterion is fulfilled. The technology transfer report can be documented by both transferring and transferred parties who should reach an agreement regarding its contents. 7

8. Premises The SU should give data to the RU on the layout, construction and quality of buildings and services [Heating, Ventilation and Air-Conditioning (HVAC), relative humidity, power, water, temperature, and compressed air] , which influence the product, process, or procedure to be transferred. The SU should give data on important health, safety and environmental issues: Characteristic risks of the manufacturing methods ( e.g., reactive chemical hazards, exposure limits, fire and explosion risks), 8

9. 2)Health and safety necessities for reducing operator exposure e.g., ( atmospheric restraint of pharmaceutical dust), 3)Emergency planning concerns (e.g., in events of spillage, gas or dust release, fire and firewater run-off), and 4)Recognition of waste streams and requirements for re -use, recycling and/ or disposal. 9

10. Equipment The SU should give a list of equipment, b rands and models used in the filling, manufacture, packing and or control of the product, procedure to be transferred, along with the prevailing qualification and confirmation documentation. Important documentation may include: Drawings, Manuals, Maintenance logs, 10

11. 4) Calibration logs, and 5) Procedures ( e.g., regarding equipment set -up, operation, cleaning, maintenance, calibration, and storage The RU should assess the data given by the SU along with its own inventory list with the qualification status (IQ, OQ , and PQ) of every equipment and system, and simultaneously compare the equipment at the two sites in relation to their functionality, models, and qualification status. 11

12. The RU should perform a gap analysis for identifying the necessities for modification of prevailing equipment, procurement of new equipment, or an alteration in the process, to allow the RU to replicate the process being transferred. GMP requirements should be followed and intended production volumes and batch sizes ( e.g., same, scale -up, or campaign) should be contemplated. 12

13. Factors to be compared are as follows: 1) Minimum and maximum capacity, 2) Construction material, 3) Critical operating parameters, 4) Critical equipment components ( e.g., filters, screens, and temperature/ pressure sensors), 5) Critical quality attribute, and 6) Range of intended use 13

14. Qualification and validation Qualification: Action of proving and documenting that any equipment, utilities and systems actually and consistently leads to the expected result Qualification should be completed before process validation is performed. The process of qualification is • logical, Systematic process should start from the design phase of the premises, equipment,utilities . 14

15. There are four stages of qualification: Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ). All SOPs for operation, maintenance and calibration should be prepared during qualification Training should be provided to operators and training records should be maintaine d 15

16. Design Qualification: Documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of GMP. 2) Installation qualification (1Q): Installation qualification should provide documented evidence that the installation was complete, satisfactory and operate in accordance with established specifications 16

17. Installation qualification verified The purchase specifications, drawings, manuals, spare parts lists and Vendor details 17

18. 3) Operational qualification (OQ): Operational qualification should provide documented evidence that utilities, systems or equipment and all its components operate in accordance with operational specifications. Operation controls, alarms, switches, displays and other operational components should be tested. 4) Performance qualification (PQ): Performance qualification should provide documented evidence that utilities, systems or equipment and all its components can consistently perform in accordance with the specifications under routine use. 18

19. Test results should be collected over a suitable period of time to prove consistency. Requalification: Requalification should be done in accordance with a defined schedule. The frequency of requalification may be determined on the basis on factor such as the analysis of results relating to calibration, verification and maintenance. •There should be periodic requalification, as well as requalification after changes (such as changes to utilities, systems, equipment; maintenance work; and movement) 19

20. Validation Definition: Validation is the action of proving that any procedure, process, equipment, method, material or activities actually leads to the expected results and produce a quality products. Documentation associated with validation includes: Standard Operating Procedures(SOPs) Specifications Validation Master Plan(VMP) Qualification Protocols and Reports Validation Protocols and Reports. 20

21. 21 Resources required to implement validation : • Time: rigorous times sc hedules . •Financial: time of specialized personnel and expensive technology. •Human: collaboration of experts from various disciplines e.g. a multidisciplinary team, comprising quality assurance, engineering, manufacturing and other disciplines, depending on the product and process to be validated.

22. Validation Master Plan (VMP) Definition: It is a high-level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach,to be used for establishing performance adequacy. It provides information on the manufacturer’s validation work programme and defines details of and time scales for the validation work to be performed It should reflect the key elements of the validation programme 22

23. It should be concise and clear and contain at least the following information: a validation policy organizational structure of validation activities summary of facilities, sytems,equipment and processes validation and to be validated, documentation format( e.g.protocol and report format) Planning and scheduling change control References to existing documents 23

24. Validation Protocol Definition: A document describing the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process part of routine use. A protocols should include The objectives of the study the site of the study the responsible personnel description of SOPs to be followed equipment to be used; standards and criteria for the relevant products and processes 24

25. the type of validation The processes and/or parameters sampling, testing and monitoring requirements predetermined acceptance criteria for drawing conclusion Revalidation: Definition: Re-validation provides the evidence that changes in a process and/or the process environment, introduced either intentionally or unintentionally, do not adversely affect process characteristics and product quality. 25

26. There are two basic categories of Re-validation: •Re-validation in cases of known change (including transfer of processes from one company to another or from one site to another), • Periodic Re-validation carried out at scheduled intervals Changes that are likely to require Re-validation follows: Changes of raw materials (physical properties such as density, viscosity, particle size distribution may affect the process or product), Change of starting material . 26

27. Changes of packaging material ( e.g.substituting plastic for glass), Changes in the process ( e.g.mixing times,drying temperatures), Changes in the equipment ( e.g.addition of automatic detection systems). Changes of equipment Production area and support system changes (e.g. rearrangement of areas, new water treatment method), Transfer of processes to another site 27

28. REFERENCES: https://www.slideshare.net/slideshow/pharmaceutical-process-validationpptx/67278553 A textbook of industrial pharmacy II by Dr. Ilango K. B, Dr. v.k . Shukla, Dr. S. H. Lakde First edition 2020 published by Thakur Publication page no. 52 to 54 28

29. Thank you for your attention ! 29