API GMP Guidance - Intent and Application of ICH Q7
For Pharmaceutical, Biopharmaceutical
and Allied Industries
Addressing Issues on Regulatory Requirements,
Guidelines and Practical Approaches to API’s Manufacturing
This comprehensive 2-day program was developed
along with FDA to train both regulatory (FDA)
and Industry personnel. It was written by members
of the ICH Q7A Expert Work Group and designed
to teach both the meaning and intent of the API
GMP.
The instructor was a voting member of the EWG
that negotiated and wrote the Q7A Guidance as
it has been adopted by the regulatory bodies in
the USA, EU, and Japan.
Join This Important, Two Day Comprehensive &
Interactive Course with Discussions on:
- GMP considerations related to ICHQ7
- History of API GMP Development
- Requirements and Implementation of ICHQ7
- Costs and benefits of manufacturing excipients
in compliance with ICHQ7A guidelines
- Quality Management and Creating Quality Units
- Records and Documentation
- Differences in Registration for Market Authorizations
- Material Management
- Managing Complaints and Recalls
- Impact of ICHQ7 on Second and Third Parties
- Evaluation of Suppliers
- Cleaning Validation
- Labeling of APIs and Intermediates
- GMP in Laboratory Control
- Change Control
- Differences between API’s manufactured by
Cell Culture(&)/ Fermentation to API’s manufactured
by Chemical Synthesis
- Audit Preparation with Consideration to GMP
and ICH Requirements
As of 30th October 2005 EU law mandated manufacturers
of medicinal and veterinary products for sale
in the EU to use only APIs that have been produced
in compliance with GMP (ICHQ7a).
It is important that API production facilities
operating under different national and international
regulatory authorities not be required to meet
diverse standards. For this reason, an Expert
Working Group in ICH developed the ICH-Q7 document
as a single standard that all suppliers must apply
to production of APIs used in human drug products
manufactured in any of the ICH signatory regions.
Distinguished Course Leader
Mr. Max Lazar
President
FDA Regulatory Compliance
Consulting
For his contribution to Q7A, Max Lazar was
awarded the USA FDA Commissioner’s Special Citation
“For outstanding cooperation and achievement
in developing an internationally harmonized
good manufacturing practice guidance for active
pharmaceutical ingredients used in human drug
products.”
Max Lazar retired from Hoffmann-La Roche Inc.
in 2001 after 35 years, where he was Vice President,
FDA & DEA Compliance. In that position he
was responsible for compliance oversight of
all of the Roche USA businesses including Active
Pharmaceutical Ingredients, Pharmaceuticals
(Solid, Liquid, and Sterile), R&D, Diagnostics,
Fine Chemicals and Vitamins. Following his retirement,
he established a consulting business specializing
in API GMP issues and the training of personnel
covering the ICH Q7A Guidance. As a voting member
of the ICH Expert Work Group (EWG) that developed
and negotiated this new international standard,
Max is uniquely qualified to share and explain
the EWG’s intent of this new guidance. His involvement
in this new API GMP pre-dates the ICH activity
itself.
His more than 40-year career in the Pharmaceutical
Industry includes numerous memberships and chairs
of committees. He founded and chaired the Pharmaceutical
Manufacturers Association’s Bulk Pharmaceutical
Committee of the Quality Control Section. This
chair lasted thru the reorganization of PMA
into PhRMA and until Max’s retirement in 2001.
He has presented at numerous meetings and training
programs including SOCMA, PDA, DIA, PhRMA, Barnett,
and IIR both domestically and overseas.
Max was named Topic Leader for the Pharmaceutical
Research and Manufacturers Association’s (PhRMA)
ICH Q7A team that developed the API GMP document
for ICH. He represented USA industry at the
PIC/S Canberra Conference which preceded the
ICH API activities and worked with FDA during
the 1980 – 2000 era addressing all of the API
industry related regulatory issues including
the 1987 NDA Re-Write Guidelines and GMP activities.
He was one of five invited industry representatives
at the WHO/CDC/FDA Diethylene Glycol Contamination
Prevention Workshop that followed the Haitian
tragedy where almost 100 children died. This
workshop developed recommendations for consideration
by the Pan American Health Organization and
WHO. Max was named as PhRMA’s representative
on the FDA PQRI initiative that developed the
initial Bulk Substance projects.
He was Vice Chair of the USP Pharmaceutical
Waters Expert Committee (2000-2005) and has
been re-elected to another 5-year term (2005-2010)
as a member on this USP Expert committee. He
conducts training and consultations on API GMP
(ICH Q7A) and other FDA Compliance issues. While
specializing in API, Max’s experience provides
him with expertise in many areas of FDA compliance
including laboratory, documentation, sterile
and oral dosage forms as well as devices, diagnostics
and radiopharmaceuticals.
He is a member of numerous professional organizations.
He is on the Editorial Board of the Journal
of GXP Compliance. Max is listed in numerous
editions of Who’s Who including Who’s Who in
America and is a graduate of Brooklyn College
of the City University of New York. He has contributed
to several books dealing with APIs, and has
written and published several guidances covering
Bulk Pharmaceutical Chemicals (API) as chair
of the PhRMA and PMA Bulk QC Committee and Workgroups.
He is resides in Surprise, AZ.
Program Agenda
| Day 1 |
Wednesday, May 21st,
2008 |
| 8:00 AM |
Registration and
Continental Breakfast |
| 8:30 AM |
Course Begins |
| 10:15 AM |
Mid-Morning Refreshment
Break |
| 12:00 PM |
Luncheon |
| 1:15 PM |
Day One Continues |
| 2:45 PM |
Mid-Afternoon Refreshment |
| 4:15 PM |
Questions & Answers |
| 4.30 PM |
Conclusion of Day
One |
| Day 2 |
Thursday, May 22nd,
2008 |
| 8:00 AM |
Continental Breakfast |
| 8:30 AM |
Day Two Course Begins |
| 10:15 AM |
Mid-Morning Refreshment
Break |
| 12:00 PM |
Luncheon |
| 1:00 PM |
Day Two Continues |
| 2:30 PM |
Questions & Answers |
| 3:00 PM |
Conclusion of the
program |
Program Content
| Day 1 |
Wednesday, May 21st,
2008 |
| 8:30 AM - 4:30 PM |
I. Background and
History
a. What is ICH and who negotiated Q7A?
b. Why is there so much detail included
in the guidance?
c. How did we get to Q7A – sharing insider
information
d. Is it truly an international guidance?
II. Section 1 - Introduction
a. Applying Q7A in the real world
b. Where does an API process begin?
c. Why is it important to identify the
API Starting Material?
III. Section 2 - Quality Management
a. Responsibilities of Quality and Production
Activities
b. What Quality responsibilities can or
cannot be delegated?
IV. Section 3 - Personnel
a. Qualification and Training
b. Hygiene
c. Use of Consultants
V. Section 4 - Buildings and Facilities
a. Design and Construction
b. Utilities
VI. Section 5 and 12.7 - Process Equipment
and Cleaning Validation
a. Equipment Design and Construction
b. Cleaning in an API Process
c. Validation of API Cleaning
VII. Section 6 - Documentation and Records
a. A Documentation System should exist
b. What types of Records should exist
and what Reviews and Approvals are expected?
c. What Production and Laboratory records
are necessary?
VIII. Section 7 - Materials Management
a. What types of procedures are needed?
b. What Material Management procedures
should exist?
IX. Section 8 - Production and In-Process
Controls
a. Critical Operations – What is critical?
b. Yields – The behind the scenes discussions
about this item.
c. Deviations – Documentation and Investigations
expected
X. Section 9 - Packaging and Identification
a. Procedures and materials
b. Label issuance and controls expected
c. Labeling of APIs and Intermediates
XI. Section 10 - Storage and Distribution
a. Warehouse and Storage records
b. Distribution and Transfer expectations
c. Transport and Labels
|
| Day 2 |
Thursday, May 22nd,
2008 |
| 8:30 AM - 3:00
PM |
XII. Section 11 -
Laboratory Controls
a. Are there any differences between
API and Drug Product requirements?
b. What should records document?
c. Reference Standards discussed
d. Why is an impurity profile important?
e. Stability programs
XIII. Section 12 and 19.6 - Process Validation
a. What process validation is NOT!
b. What types of validation is acceptable
for API
c. What flexibility exists for API?
XIV. Section 13 - Change Control
a. When is change control needed?
b. Notification requirements
XV. Section 14 - Rejection and Reuse of
Materials
a. What is the difference between reprocessing
and rework?
b. Be careful what you call it!
c. Material recovery expectations
d. What are acceptable practices?
XVI. Section 15 - Complaints and Recalls
a. Are there any specific requirements?
XVII. Section 16 - Contract Manufacturers
(Including Laboratories)
a. What does Q7A expect for the use of
contract manufacturers
b. What responsibility does the holder
of the drug authorization or NDA retain
under Q7A?
XVIII. Section 17 - Agents, Brokers, Traders,
Distributors, Repackers, and Relabellers
a. Why does this section even exist?
b. Why did the Experts that negotiated
the guidance include these requirements?
c. Why is communication critical?
XIX. Section 18 - Cell Culture/Fermentation
a. Why was this section even written?
b. Is this section “information” or a
“requirement”?
XX. Section 19 - APIs For Use in Clinical
Trials
a. Is this section appropriately titled?
b. Why was it written?
c. What was the true intention of the
Experts that wrote and negotiated the
guidance?
|
Who Should Attend?
This two-day, comprehensive training workshop
is designed for all persons involved in the manufacture
of APIs (either chemically, or by cell culture/fermentation)
especially for persons from
- Quality Assurance
- Quality Control
- Pilot and Commercial Production
- Auditors of the Manufacturing Authorization
Holders
- Regulatory Affairs
- Qualified Persons
- Technical Services
- Process Development
- Engineering
- Validation
- Purchasing
- Training
- Contract Laboratory & Manufacturing
- Consultants
Registration Information:
Registration Fee: $985.00 +
GST
Online Registration
Payment Information
Course Location
and Hotel Accommodations
Registration
Fee Includes:
Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions
Policy:
CANCELLATION POLICY:
Cancellation is accepted in writing (by mail,
or fax) up to 4 weeks before the program start
date, after which cancellations are not accepted
and do not qualify for refund or credit. All Cancellations
are subject to a $212.00 CAD (incl. GST)/person
processing fee. Substitution of delegate/s with
the member/s of the same organization is permitted
at any time. IPA reserves the right to postpone
an event, prior to which time all the registered
attendees will be notified a minimum of 2 weeks
in advance. IPA shall not be responsible for any
air fare, hotel or transportation costs incurred
by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance
upon completion of the course
For registration or any further
information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
|
