Current Good Laboratory Practices & Current Good Manufacturing Practices - A Basic Primer

The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings with the US FDA and similar European organizations. It will benefit professionals who are new to the pharmaceutical industry and also those who need refresher training.

Learning Objectives

Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory / Good Manufacturing Practice guidelines are in effect within their organization will have a thorough understanding of the current regulations (mandated by the USFDA and the International Conference on Harmonization), the necessity of rigorously implementing them in their groups, monitoring compliance in their and the collaborator’s organizations and incorporating this thinking in all scientific matters. The course will also discuss the consequences of non-compliance.

Course Description

This course is intended to give participants an introduction to Good Laboratory / Good Manufacturing Practice regulations and their application to laboratory studies and for manufacturing. This course will also provide participants with an understanding of terminology for laboratory studies and the role GLPs / GMPs play in assuring the validity of these studies. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.

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COURSE AGENDA

DAY ONE – (9:00am – 5:00pm)

Session 1:

General Introduction and Glossary of Terminology:

• Regulatory milestones in the progress of a drug from conception to commercialization: what is the US drug approval process?
• The necessity of adhering to stringent specifications of GLP. Specific examples of the consequences of non-compliance will be presented
• History of GLP / GMP; FDA regulation of pre-clinical testing?
• What are the differences between GLP / GMP and ISO 9000 regulations? Is GLP / GMP compatible with Total Quality Management?
• Role of GLP for pre-clinical R & D: How are safety, quality and uniformity of the product ensured? Key data integrity review points

Session 2:

Organization and Management Systems:

• General provisions and salient features of GLP / GMP
• Organization and management structure: regulatory implications;
• Involvement of personnel in synthesis, analytical, toxicology, metabolism and related functions
• Construction of organograms, mission statement and quality goals, enumeration of services provided by each department
• Requirements for training of staff and documentation of such training: certification of employees, job competency standards, job descriptions, continuing education programs and annual refreshers
• Maintenance of resumes, staff training records and resumes documenting qualifications and experience of consultants
• Writing an effective curriculum vitae; designing flow charts to depict document pedigrees, project management, decision making and documentation, material flow and disposition; product files; storage, archiving and retrieval of data
• Study Directors and Quality Control Units: Basic Requirements

Session 3:

Pharmacology and Toxicology:

• General comments on pharmacology, toxicology etc Comments on disqualification of testing facilities
• Care and Maintenance of animal care facilities, specimen and data storage facilities, reagents and solutions
• Non-Clinical Laboratory Study:
• Protocol for a non-clinical Lab study

Session 4:

Notebooks, Logbooks and Patents: Storage and Archiving Of Data:

• Maintaining a laboratory notebook--Do's and Don'ts: Patent law and regulatory constraints; changes in US law for foreign inventors; electronic signatures, batch records and documents, electronic submissions
• Raw data analysis and reports; traceability of records; rules for retention / archiving; documents needed for a patent application
• Instrument calibration, use, maintenance and repair log books

Session 5:

Standard Operating Procedures and the Core Elements of GLP

• Writing, approval and dissemination of Standard Operating Procedures; training of personnel; change control
• Qualification (Installation, operational and performance) and validation of key equipment, apparatus and computer programs
• Protocols for identity testing of laboratory reagents; quarantine and QC release; expiration date testing of intermediates and products; reference standards
• Impurity profiles, stability of drugs, degradates and metabolites, retaining samples
• The Barr decision; out of specification results; retesting, resampling and remixing; deviations; ICH requirements for analytical procedures

DAY TWO (8:30am – 5:00pm)

Session 1:

Drug Substance:

• Basic Information about needed data; presentation requirements

Session 2:

Drug Product:

• Basic Information about needed data; presentation requirements

Session 3:

Validation:

• Validation: Bulk Pharmaceutical Chemical vs. Dosage Form
• Biobatch relationship, raw materials, manufacturing directions, equipment, in-process controls, test results, investigations / product failures
• Establishment of limits for cleaning validation
• Control of BPC processes: "Control all steps and validate critical ones approach"; prospective, concurrent and retrospective validation
• PhRMA guidelines for production, packing and holding of drug substances
• Process Analytical Technologies (PAT)

Session 4:

Technology Transfer, Quality Audits and Laboratory Certification:

• Writing process and technology transfer reports
• Necessary documentation and preparation for pre- approval inspections
• Laboratory certification; internal quality audits of laboratory operations
• Conducting a quality audit: A sample questionnaire / audit checklist

Session 5:

The FDA Audit:
• Dealing with the FDA: Procedures and policies for inspections
• Receiving the FDA inspector: have you written an SOP for this?
• Do's and Don’ts: Conducting yourself during an audit; precautions
• The exit interview: FDA 483' s-- Your rights, duties and obligations
• Post-approval GLP compliance

DAY THREE (8:30am – 1:00pm)

Session 1:

Issued involved in Outsourcing:

• FDA guidelines for inspection of BPCs
• FDA policies on development of enantiomerically pure drugs
• Ancilliarisation: Vendor site validation; strategies for sourcing of Intermediates

Session 2:

Quality Audits and Laboratory Certification Programs:

• Laboratory certification; internal quality audits of laboratory operations
• Conducting a quality audit: A sample questionnaire / audit checklist

Session 3:

The FDA Audit:

• Dealing with the FDA: Procedures and policies for inspections
• Receiving the FDA inspector: have you written an SOP for this?
• Do's and Don’ts: Conducting yourself during an audit; precautions
• The exit interview: FDA 483' s-- Your rights, duties and obligations
• Post-approval GLP compliance

Session 4:

Regulatory requirements affiliated with filing an IND for New Chemical/Molecular Entities (NCE's and NME’s):

• General Comments on Pharmacology, Toxicology etc.

Ample opportunities will be available for question-answer sessions and discussions