Hetero Drugs Limited - The Indian Pharmaceutical … 3 of 30 3 Hetero Drugs Limited Laws Governing...

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Hetero Drugs Limited

Global Challenges in Quality Assurance of APIs

The Perspective of Indian Manufacturers

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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)

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Additional requirements by ICH, adopted by Authorities

ICH Q7

Adoption of Q8, Q9, Q10 Principles to Drug Substance

ICH Q11

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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.

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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.

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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

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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.

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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

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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.

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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.

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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)

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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

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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

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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

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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.

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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.

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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.

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Emphasis

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

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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)

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Technologies

Others (Specifications/Process changes)

Skilled Manpower

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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)

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Current Challenges

GDUFA – USFDA

Industry has already begun working on the plans to meet the requirements of the new regulation, starting October, 2013

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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

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Hetero Drugs Limited - The Indian Pharmaceutical … 3 of 30 3 Hetero Drugs Limited Laws Governing...

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