GMP for Quality Control and Contract Laboratories
Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. Thatดs the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483ดs and warning letters demonstrate that companies have problems with implementation.
This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
Why should you attend?
Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
Understand and be able to explain your companyดs quality plan or laboratory compliance master plan.
Understand the difference between GMP and non-GMP laboratories.
Learn how to develop inspection ready documentation.
Be able to train others in your organization on GMP requirements.
Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.
Who will benefit:
Analysts and Lab Managers
QA Managers and Personnel
Human Resources (HR) Managers and Staff
Quality control laboratories
Suppliers and service providers of instruments and computer systems
Day 1 Schedule:
Lecture 1: FDA Regulations and Requirements Overview
FDA 21 CFR Part 211 and 21 CFR Part 11
Most frequently cited FDA 483s and warning letters
Requirements overview from sampling to archiving
Quality system requirements, e.g., ICH Q10
The concept and practice of risk based compliance
Lecture 2: Planning for quality and cGMP compliance
Developing and using a validation master plan
Scope, objectives and key elements of the master plan
Developing and using FDA compliant SOPs
Using templates to generate inspection ready documentation
Planning for efficiency cost-effectiveness
Lecture 3: Calibration and Qualification of Laboratory Equipment
USP chapter <1058> for instrument qualification
Going through examples for qualification steps(DQ, IQ, OQ, PQ)
SOPs and deliverables for three instrument categories
Developing calibration and qualification protocols
Lecture 4: Equipment Maintenance and Change control
Preventive maintenance; tasks, documentation
Planned and unplanned changes
Changing hardware, firmware, documentation
Definition and handling of like-for-like changes.
Requalification: time and event based
Lecture 5: Validation of Laboratory Computer Systems
Going through the new GAMPฎ guide: "A Risk based Approach to Laboratory Computerized Systems"
Going through a complete laboratory computer system validation from beginning to end
Integration the GAMPฎ guide with USP <1058>
Periodic evaluation to reduce revalidation efforts
Revalidation: why, what, when
Lecture 6: Validation of Analytical Methods and Procedures
Parameters and tests according to ICH Q2
Developing a validation plan, protocols and a report
Setting acceptance criteria for different applications
Verification of compendia methods according to USP
Transfer of analytical procedures according to the new USP
Day 2 Schedule:
Lecture 1: Sample Testing: Preparation, conduct, documentation
Preparing the equipment
Setting specifications and acceptance criteria
Documentation of test results
Review and approval
Not to forget: Review of electronic audit trail
Lecture 2: Handling out of specification (OOS) test results
Going through the FDA OOS guide
Learning from recent FDA warning letters
Going through an OOS checklist
Using out of trend (OOT) data to avoid OOS results
Documentation and follow-up: root cause, corrective action plan, preventive action plan
Lecture 3: Quality assurance of reference standards and other supplies
Supplier qualification vs. sample testing
Selection and assessment of suppliers
Retesting of materials
Preparing working standards from reference standards
Correct labeling of chemicals
Lecture 4: Training for GMP compliance
identification of training needs
Developing a training plan
Making GMP training interesting
Documenting effectiveness of training
Lecture 5: Ensuring Integrity of Raw Data and Other records
FDA Part 11 and EU-PIC/S Annex 11 requirements
Definition of Raw Data: Electronic vs. paper
Acquisition and recording of raw data
The importance of electronic audit trail
Archiving of electronic records for ดready retrievalด
Lecture 6: Internal audits in preparation for FDA inspection
Scheduling of audits
FDA Inspections as model for laboratory audits
Going through a typical FDA laboratory inspection
Responding to Typical inspectional/audit deviation
How to avoid FDA 483s and warning letters
Lecture 7: Wrap up - Final questions and answers
Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Agilent Technologies
Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
Served as team member of PDAดs task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMPฎ special interest group on Laboratory Systems.
Presenter of the Year of the Institute for Validation and Technology
Director and chief editor of
labcompliance, the global on-line resource for validation and compliance issues for laboratories.
Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"