Mukund Chorghade

I

2 Hours

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 cGLP / cGMP. Specific examples of the consequences of non-compliance will be presented.
• History of cGLP / cGMP; FDA regulation of pre-clinical testing?
• What are the differences between cGMP and ISO 9000 regulations?
• Is cGMP compatible with Total Quality Management?
• Role of cGMP for clinical R & D: How are safety, quality and uniformity of the product ensured? Key data integrity review points.

Mukund Chorghade

II

2 hours

Organization and management systems:

• General provisions and salient features of cGLP / cGMP.
• 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 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.

Mukund Chorghade

III

1 hour

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
  

Veena Chorghade

IV

2 hours

Standard Operating Procedures and the core elements of cGLP / cGMP:

• 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, degradants and metabolites,
  retaining samples.
• The Barr decision; out of specification results; retesting, resampling
  and remixing; deviations; ICH requirements for analytical procedures.

Veena Chorghade

I

2 hours

Validation:

• Validation: Bulk Pharmaceutical Chemical vs. Dosage Form.
• Validation of Solid Dosage Forms: Biobatch relationship, raw materials, manufacturing directions, equipment, granulation / mix analysis, in-process controls, test results, investigations / product failures.
• Sampling size and process control of mixing; scale of scrutiny.
• 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.

Mukund Chorghade

II

2 hours

Technology Transfer Issues:

• Writing process and technology transfer reports.
• How to transfer bulk pharmaceutical chemical technology from chemical development to manufacturing.
• Necessary documentation and preparation for pre- approval inspections.

Mukund Chorghade

III

2 hours

Outsourcing Issues:

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

Mukund Chorghade

I

1 hour

Quality Audits and Laboratory Certification Programs:

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

Mukund Chorghade

II

1 hour

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 cGLP / cGMP compliance.
  

III

1.5 hours

Miscellaneous:

• FDA videos on safety and GMP (Q&A - Discussion time after)

IV

V