Hetero Drugs Limited

Transcription

1 Global Challenges in Quality Assurance of APIs The Perspective of Indian Manufacturers Slide 1 of 30 1

2 Slide 2 of 30 2

3 Laws Governing GMPs/Quality United States Food, Drugs and Cosmetics Act Europe European Pharmaceutical Legislation GMPs for APIs India Drug and Cosmetic Act (Schedule M APIs) Slide 3 of 30 3

4 Additional requirements by ICH, adopted by Authorities ICH Q7 Adoption of Q8, Q9, Q10 Principles to Drug Substance ICH Q11 Slide 4 of 30 4

5 Inspection History In India The Evolutionary Process Early 1980s The Start of FDA Inspections for sites in India Early 2000s The start of WHO Inspections Mid 2000s The onset of European Inspections, TGA Inspections etc. Slide 5 of 30 5

6 Inspection History In India The Evolutionary Process Increased number of API manufacturing facilities with Approvals from Agencies, over the past decade Success Rates in terms of the inspections of the APIs by Authorities such as USFDA, EU Agencies, EDQM, TGA, etc., reflects the commitment by the API manufacturers to gear up to the continuous changes in the Regulations and their implementation. Slide 6 of 30 6

7 Inspection History In India The Evolutionary Process Several Companies from India are part of WHO Pre- Qualification Programme particularly for the Supply of Anti-Retroviral APIs, reflecting the efforts of the API manufacturers to ensure compliance to the Stringent Requirements in terms of Quality and adherence to cgmps Slide 7 of 30 7

8 Inspection History In India The Evolutionary Process The number of the Firms that supply the APIs to the Highly Regulated Markets like US, Canada, Europe, Australia, Japan have increased over the past few years, reflecting the understanding that these organizations have gained on the Laws governing the Supplies of the Pharmaceuticals / APIs in those countries. Slide 8 of 30 8

9 Inspection History In India The Evolutionary Process Efforts and steps increased manifold by the Manufacturers to imbibe the philosophy of building in Quality right from the Development of the process to Distribution of the API, minimizing all the risks associated with the manufacture Slide 9 of 30 9

10 Changes in Inspectional Approaches Preparedness of Industry The Approach by the Inspectors adopted by the Inspectors from Different Authorities changed over the period of time, with the stress being on Documentation at some time and on the Practices at some time, ultimately culminating into the Stress on The Quality Management Systems as a whole, thus laying the importance on the Involvement of Top Management of the Firms in implementation and propagation of the current Regulatory Requirements. Slide 10 of 30 10

11 Changes in Inspectional Approaches Preparedness of Industry Thus, the most important aspect in the current Scenario is that the Improvements could be expedited with the decision-making Authorities themselves getting involved, following the systems, within the Regulatory Framework. Slide 11 of 30 11

12 Regulatory Submissions Quality Aspects Changing Approaches to Submissions Quality of Information /Adequacy Increased levels of Criticality in Evaluation of process vis-à-vis Specifications Time-bound review framework response in time (Particularly the Centralised / Decentralised Procedures approach in the EU) Slide 12 of 30 12

13 Regulatory Submissions Quality Aspects Understanding on Variations Current Scenario in the US/Europe and other Regulated Markets Minimizing queries and speedier response, following the right approach ( from development to commercial Slide 13 of 30 13

14 Regulatory Submissions Quality Aspects The Indian API manufacturers are geared up to meet all the current challenges posed w.r.t the review process, of particular importance to mention is the current trend on the queries related to the Impurities of Genotoxic concerns and Definition of Starting Materials Slide 14 of 30 14

15 Regulatory Submissions Quality Aspects Proactive approach in the Choice of the Process, thus optimising the specifications in terms of the Impurities, adoption of the suitable validated methods, use of advanced techniques in Characterisation are the important aspects of current day API Development Slide 15 of 30 15

16 Emphasis The Emphasis of API Manufacturers has always been on continuous improvement to meet the changing dynamics of a Regulated Environment The Primary requirement in this scenario is to have Trained Staff who upgrade by understanding the current Regulations. Slide 16 of 30 16

17 Emphasis Periodic Training to all levels of Staff in various functions related to the Manufacture to ensure current Understanding w.r.t. Regulations / Guidances Periodic Self Audits to ensure compliance to the Quality Systems and initiating the necessary actions to improve the system. Slide 17 of 30 17

18 Emphasis Continuously improving upon the Procedures (SOPS), Documentation and Record-keeping is also on of the most important aspect which the Industry is always focused on. Improvement followed by Implementation in addition to constant monitoring and reviews are also part of the current systems being followed. Slide 18 of 30 18

19 Emphasis Emphasis is also on learning from past Industry experiences, Inspection Observations, etc., as part of improvement. Slide 19 of 30 19

20 Operational Challenges vis-à-vis Complexities of API Manufacture - Maintaining the Quality Facilities ( w.r.t product nature, e.g. Oncology, Hormones, High Potent Drugs etc.) Equipment (Design based on technologies adopted) Slide 20 of 30 20

21 Operational Challenges vis-à-vis Complexities of API Manufacture - Maintaining the Quality Technologies Others (Specifications/Process changes) Skilled Manpower Slide 21 of 30 21

22 Operational Challenges vis-à-vis Complexities of API Manufacture - Maintaining the Quality The Operations of the API Facilities need to be in sync with the changing dynamics, particularly w.r.t to the current Regulatory scenario, thus constantly upgrading within the limits of the Regulations, without affecting the Approval status of the Marketing Authorisations (of the Finished dosage manufacturer) Slide 22 of 30 22

23 Current Challenges GDUFA USFDA Industry has already begun working on the plans to meet the requirements of the new regulation, starting October, 2013 Slide 23 of 30 23

24 Current Challenges New EU Directive for Importing APIs The Industry is already in discussion with the Government of India in trying to find the right approach to meet the New regulations of European Authority Slide 24 of 30 24

25 THANK YOU Slide 25 of 30 25