cgmp

CGMP

refers to the Current Good Manufacturing Practice regulations enforced by the Food and Drug Administration (FDA)

CGMP

provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities

PIC/S

Pharmaceutical Inspection Convention Scheme

PIC/S

is European whereas the previous GMP regulations are based from USFDA.

PIC/S Guide to Good Manufacturing Practice

Adopted to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products.

Consequences of Non-CGMP Compliance

• Loss of confidence by industry peer and regulators.

• Adverse publicity and patient safety concerns.

• Increased attention from the regulators.

• Order to stop manufacture and sale of products.

• Products withdrawn from the market.

• Prosecution and imprisonment for individuals (in the US).

GMP

is the part of QA which ensures products are consistently produced and controlled to the quality standards appropriate for their intended use

Pharmaceutical Quality System

Ensure that they are fit (quality) for their intended use

Pharmaceutical Quality System

Comply with the requirements of the Marketing Authorization or Clinical Trial Authorization (as appropriate)

Pharmaceutical Quality System

Do not place patients at risk due to inadequate safety, quality or efficacy.

Quality Management

It is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product.

Quality Management

It is the sum total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

Quality Management

Incorporates Good Manufacturing Practice

Good Manufacturing Practice

Part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization, Clinical Trial Authorization or product specification.

Good Manufacturing Practice

Concerned with both production and quality control.

Quality Control

• Sampling

• Specifications and testing

• Organization, documentation and release procedures

Quality Control

Ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.

Basic Requirements of Quality Control

Adequate facilities, trained personnel and approved procedures are available for sampling and testing of materials, intermediate, and finished products.

Basic Requirements of Quality Control

All test methods are validated.

Basic Requirements of Quality Control

All results are documented and any deviations are fully recorded and investigated.

Basic Requirements of Quality Control

No batch of product is released for sale or supply prior to certification by an Authorized person.

Product Quality Review

Verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product

Product Quality Review

Highlight any trends

Product Quality Review

Identify product and process improvements

Product Quality Review

Conducted and documented annually

Quality Risk Management

A systematic process for the (1) assessment, (2) control, (3) communication and (4) review of risks to the quality of the medicinal product

Quality Risk Management

It can be applied both proactively and retrospectively

Principles of Quality Risk Management

The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient

Principles of Quality Risk Management

The level of effort, formality and documentation of the Quality Risk Management process is commensurate with the level of risk

Tools of Quality Risk Management

Basic risk management facilitation methods (flowcharts, Ishikawa diagram, process maps, etc)

Tools of Quality Risk Management

Failure Mode Effects Analysis (FMEA)

Tools of Quality Risk Management

Failure Mode Effects Criticality Analysis (FMECA)

Tools of Quality Risk Management

Fault Tree Analysis (FTA)

Tools of Quality Risk Management

Hazard Analysis & Critical Control Points (HACCP)

Tools of Quality Risk Management

Hazard Operability Analysis (HAZOP)

Personnel

The correct manufacture of medicinal products relies upon people.

Personnel

There must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer.

Personnel

Individual responsibilities should be clearly understood by the individuals and recorded.

Personnel

All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.

Authorized person

Ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorization.

Head of production

Ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;

Head of production

• To approve the instructions relating to production operations and to ensure their strict implementation;

Head of production

To ensure that the production records are evaluated and signed by an authorized person;

Head of production

To ensure the qualification and maintenance of his department, premises and equipment;

Head of production

To ensure that the appropriate validations are done;

Head of quality control

To approve or reject, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products;

Head of quality control

To ensure that all necessary testing is carried out and the associated records evaluated;

Head of quality control

To approve specifications, sampling instructions, test methods and other Quality Control procedures;

Head of quality control

To approve and monitor any contract analysts;

Head of quality control

To ensure the qualification and maintenance of his/her department, premises and equipment;

Head of quality control

• To ensure that the appropriate validations are done;

Head of quality control

• To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

Training

The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.

Consultants

should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.

Consultants

Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants

Premises and Equipment

must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.

Ceilings

Suspended ceiling utilizing lay-in panels and layin lighting troffers.

Ceilings

HEPA FILTERS may be installed above the process machining.