Friday, July 09, 2010 Our Ref; ING/GEN/0810

Subject: Title:

Training Sessions for Seniors in Production and Quality System for QbD & APR “Contemporary Tools & Technology for Effective Good Manufacturing Practices” Understanding Quality by Design (QbD) & Annual Product Review Tuesday, July 6, 2010 & Tuesday, July 27, 2010 @ Karachi Marriott Hotel, Karachi

Dear Sir, We are proceeding to our last sessions from current calendar. By today, 51 Companies (National & MNCs) & 8 Institutes, 463 Persons have taken part in our 9 Training Sessions, ranging from Basic GMP, Studying Stability Studies & Product Shelf life, Validation for Aseptic & Oral Formulations, Cleaning, Change Management, Deviation Controls, Exploring Potentials in Outside Market to Advance Regulatory Forums for better Quality Systems. Dear Sir, it is generally acknowledged that “Quality cannot be tested into products; i.e. quality should be built in by design.” In our above sessions, we will discuss that how APR can be utilized to identify the critical points at different stages in our Quality System & QbD will be utilized for effective CAPA. Experts are encouraging pharmaceutical companies to increase process understanding and attain the “desired state” of solving problems using first principles. In our sessions, we will discuss Contemporary Tools & Technologies for effective GMP. Program Details are as follows;

We are sure that current session will also be attended by selective Industry Experts & Entrepreneurs for personal & organizational improvement. Summary of the program & suggested topic for discussion are enclosed for your reference & comments*.

We are expecting participation from all leading & emerging companies, and only 30 Seats are available for Industry participations, & rest are being offered to Academia, Technocrats & Regulatory Authorities. Your early confirmation for the event will facilitate us issuing your participation confirmation & will make sure your participation in the event. We request for your Participation Confirmation, as per enclosed PCS, by Saturday, July 2, 2010.

Dear Sir, we are a commercial organization & working with the leading Pakistani Industries & Personals to empower them in achieving their full potential to realize their dreams. We are always available for any of your query & suggestion for serving you better.

Regards

Hassan Ansari Sr. Manager Marketing Ingrope Information Services +92 – 322 - 3797 284 hassan.ansari@ingrope.com

*

Summary Program

for

“Contemporary Tools & Technology for Effective Good Manufacturing Practices” Tuesday, July 6, 2010 & Tuesday, July 27, 2010 @ Karachi Marriott Hotel, Karachi Quality is never an accident; It is always the result of High Intention, Sincere Effort, Intelligent Direction & Skillful Execution; It Represents the Wise Choice of many Alternatives Early eighties, USFDA proposed a requirement for preparing a written summary for each product. The purpose for this proposed GMP requirement was to provide reliable procedures for a drug manufacturer to review the quality standards for each drug product. Later, FDA revised the proposal to allow each company to establish its own procedures for the evaluation of product quality standards, by reviewing the records required by the GMPs on an annual basis. This is now commonly referred the "product annual review" (PAR) or the "annual product review" (APR). These product reviews offer us an excellent opportunity to improve our understanding of Quality, which have moved from QC to QA, followed to QbD. We understand that QbD is effectively moving toward QC again, which is Quality of Compliance now. Quality by Design (QbD) is a concept first outlined by well-known quality expert Joseph M. Juran in various publications, most notably Juran on Quality by Design. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned in the first place. ICH guidelines Q8 (on Pharmaceutical Development), Q9 (on Quality Risk Management), and Q10 (on Pharmaceutical Quality System) provide some assistance for manufacturers to implement Quality by Design into their own operations. In our previous sessions, we have partially discussed these guidelines in respective areas. While Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry, they have been adopted by the U.S. Food and Drug Administration (FDA) too as a vehicle for the transformation of how drugs are discovered, developed, and commercially manufactured In our session, we will discuss these points in brief, and will have comments on; o Principles of Design of Experiments (DOE) o A step-by-step QbD implementation Roadmap o QbD systematic approach for Pharmaceuticals o Annual Product Review, Concept – Practice & Experiences o Using Root Cause Analysis techniques to identify risk factors o Discussion of the needs for User Requirement Specifications (URS) o How to use Knowledge space (Science base), Design space (DS), Normal Operating space (Range), Control space (Range), and Design Reviews to support QbD implementation We request all experts & industry Gurus to comment on the summary program. We will appreciate.

Regards

M. Ali Hassni
ali@ingrope.com Chief Executive, Repharm Services Chief Executive, Ingrope Information Cell: +92 – 300 – 820 – 6276
*Summary Program is provisional & subject to change as per expert opinion being received. You may also comment on some specific topic for modification. Final program will be offered before Event Day. Thanks. Ingrope Information Service