Good Manufacturing Practices (GMP) and Inspections

Outline and Objectives of presentation

Introduce WHO GMP texts
Main principles
Supplements
Others
In the context of Prequalification
Current and future approaches
Inspections in prequalification

Good Manufacturing Practices (GMP) and Inspections

A critical deficiency was defined as a deficiency which had
produced, or led to a significant risk of producing, either a
product which was harmful to the human patient or a product
which could result in a harmful residue in a food producing
animal.
A major deficiency was defined as a non-critical deficiency,
which had produced or might produce a product which did not
comply with its marketing authorisation.
A minor deficiency was defined as a deficiency where an
observation made could improve the quality system and quality
assurance approach of the manufacturer, but which did not have
a major impact on the quality of the product.

Good Manufacturing Practices (GMP) and Inspections

Inspection approach
Normally a "routine type" of GMP inspection
Opening meeting, follow the flow, closing meeting
On site inspection (production and quality control) and
documentation review
Quality systems approach
Modern challenges including risk assessment

Good Manufacturing Practices (GMP) and Inspections

Guiding principles:
Risk based orientation
Science based policies and standards
Integrated quality systems
International standards
Public interest

Good Manufacturing Practices (GMP) and Inspections

Product quality and performance ensured through
design (manufacturing processes)

Product and process specifications

Understanding of affect of formulation and process factors
on product quality and performance

Quality by design (build quality into the product)

Interaction between review, compliance and inspection

Good Manufacturing Practices (GMP) and Inspections

Where to start?

Premises
Principle
Important aspects to be kept in mind to ensure the suitability of
the operations to be carried out for different dosage forms and
product range:
Location
Design
Construction
Adaptation
Maintenance

12.1

Materials
Starting Materials I
Purchasing important operation
From approved suppliers if possible, direct from the
manufacturer
Specifications for materials
Consignment checks
Integrity of package
Seal intact
Corresponds with the purchase order
Delivery note
Suppliers labels
Cleaned and labelled with information
14.7 14.10

Materials

Good Manufacturing Practices (GMP) and Inspections

Utilities
HVAC
Water
Compressed air
Steam . . .

Quality Control
Separate guideline in addition to basic GMP
Part 1: Management and organization
Part 2: Materials, equipment, instruments and devices
Part 3: Working procedures and documents, and
safety in the laboratory
Part 4: Inspecting the laboratory

Good Manufacturing Practices (GMP) and Inspections

Quality control (also micro, water, environment)
Sampling and testing
Reference Standards
Specifications
Stability testing
Source/raw data
Qualification and validation

Good Manufacturing Practices (GMP) and Inspections

Other aspects to look at include:
Validation (process, cleaning etc)
CAPA, failure investigation
Change control
Deviations
Complaints
Product quality review

Good Manufacturing Practices (GMP) and Inspections

Planning and conduct of inspection
Type of product(s)
Type of material(s)
Premises
Changes (deviations, additional products, cleaning
procedure, campaigns etc)
Utilities and applications