Good Manufacturing Practice (GMP) certification scheme can assist manufacturers of food products and

food
related products to provide assurance to their customers that their products are manufactured in a hygienic
manner and in accordance to best practices in manufacturing.
Since GMP is one of the pre-requisite programmes (PRP) required to be established before Hazard
Analysis
and Critical Control Points (HACCP) can be implemented, having GMP certification would definitely
pave the
way to an easier HACCP implementation and certification.
Generally, GMP consists of aspects such as design and facilities in the establishment, control of
operations
by equipment, temperature, time, pH or water activity control, maintenance and sanitation, personal
hygiene,
personnel training, transportation, conveyors, product information and consumer awareness. In short, it
comprises the basic requirements of a manufacturing facility covering establishment, infrastructure,
equipment
design, construction, maintenance, process controls and personnel hygiene and awareness.
MS 1514 is the standard for prescribing the requirements of pre-requisite programmes which is required
to be
established before the implementation of HACCP. The standard is applicable to all food manufacturers,
primary
and secondary processors, food catering and service operators, food retailers and food related industries.

Course Content

Welcome, Introduction, Presentation of

the Speaker
8.30 - 9.30 Regulations in Europe

 Directives
 Guidelines
 Notices

Regulations in the USA

 CFR
 Guidances
 FOI

Harmonised Regulations

 WHO
 PIC
  ICH
 GHTF
 ISO

9.30 - 10.45 GMP in Manufacturing

 Quality of Starting Material

 Production Process
 Packaging and Storage
 Contract Manufacturing
 Responsibility

10.45 - 11.00 Break

11.00 - 12.15 GMP in Quality Control

 Duties of Quality Control

 Differences Between Europe And
USA
 Qualified Person
 Validation of Analytical Methods
 Performance of Analytical Methods

12.15 - 13.15 Lunch

13.15 - 14.30 Documentation

 SOPs
 Batch Documentation
 Quality Control Documentation
 GMP-Based Documentation
 GMP Relevant Documents
 Archiving

14.30 - 14.45 Break

14.45 - 15.45  Qualification and Validation

 Definition and Differences

 Validation Master Plan
 Validation Team/Performance of
Validation
  Responsibilities

15.45 - 16.45 Change Management

 Deviation
 Change
 Definition and Differences
 Out of Specification
 SOP

16.45 - 17.15 Training and Self-Inspection

 Performance of Training
 Performance of Self-Inspections
 SOP
 Documentation