ASQ - Preparation Course for Certified Pharmaceutical GMP Professional (CPGP) Training Course in Egypt

Description:

The Certified Pharmaceutical GMP Professional understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry.  This covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations.

Contents:

                i. Regulatory Agency Governance

A. Global regulatory framework

B. Regulations and guidances

C. Mutual recognition agreements

D. Regulatory inspections

E. Enforcement actions

F. Regulatory agency reporting

G. Site master file (SMF) and drug master file (DMF)

              ii. Quality Systems

A. Quality management system (QMS)

B. Quality unit (site) management

C. Risk management

D. Training and personnel qualification

E. Change control and management

F. Investigations and corrective and preventive action (CAPA)

G. Audits and self-inspections

H. Documents and records management

I. Product quality complaints vs. adverse event reports

J. Product trend requirements

K. Supplier and contractor quality management

                III Laboratory Systems

A. Compendia (United States, Europe, and Japan)

B. Laboratory investigations of aberrant results

C. Instrument control and record-keeping

D. Specifications

E. Laboratory record-keeping and data requirements

F. Laboratory handling controls

G. Stability programs

H. Reserve samples and retains

                IV Infrastructure: Facilities, Utilities, Equipment (18 Questions)

A. Facilities

B. Utilities

C. Equipment

D. Qualification and validation

E. Maintenance and metrology systems

F. Cleaning, sanitization, and sterilization systems

G. Automated or computerized systems

H. Business continuity and disaster recovery planning

                V Materials and Supply Chain Management (15 Questions)

A. Receipt of materials

B. Sampling processes

C. Material storage, identification, and rotation

D. Shipping and distribution

E. Traceability and sourcing

F. Salvaged/returned goods and destruction

                VI Sterile and Nonsterile Manufacturing Systems (25 Questions)

A. Master batch and completed batch records

B. Production operations

C. In-process controls

D. Dispensing and weighing controls

E. Requirements for critical unit processes

F. Contamination and cross-contamination

G. Reprocessed and reworked materials

VII Filling, Packaging, Labeling (17 Questions)

A. Filling operations and controls

B. Environmental monitoring

C. In-process and finished goods inspections

D. Parenteral product inspection

E. Packaging operations and controls

F. Labeling operations and controls

G. Filling and packaging records

H. Artwork development and controls

                Product Development and Technology Transfer

A. Quality by design concepts

B. Phase-appropriate GMP requirements