Unit-2 QA – ppt – Objectives of the course ➢ Understand the c GMP aspects in a pharmaceutical – Studocu

Objectives of the course
➢ Understand the c GMP aspects in a pharmaceutical industry.
Learning outcomes
➢ Students learnt about the quality assurance and quality control parameters which affects
academics as well as pharmaceutical industry.
➢ Students learnt about the responsibilities of personnel, environmental monitoring and
sterilization of area as well as raw materials and equipment.
Subject Name: Quality Assurance Module -II
Subject Code: BP 606T

➢ Organization and Personnel-Personnel responsibilities, training, hygiene and personal records.
➢ Premises-Design, construction and plant layout, maintenance, sanitation, environmental control,
utilities and maintenance of sterile areas, control of contamination.
➢ Equipment and Raw Materials-Equipment selection, purchase specifications, maintenance,
purchase specifications and maintenance of stores for raw materials.
Structure of Module -2BP 606T
Learning Material

Principle

####### The establishment and maintenance of a satisfactory

####### system of quality assurance and the correct

####### manufacture of medicinal products relies upon people.

• For this reason there

####### must be sufficient

####### qualified personnel to

####### carry out all the tasks

####### which are the responsibility

####### of the manufacturer.

Principle

• Individual responsibilities should be clearly

####### understood by the individuals and recorded.

• 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.

General

• The manufacturer must have an organization chart.
• People in responsible positions should have specific

####### duties recorded in written job descriptions and

####### adequate authority to carry out their responsibilities.

General

• There should be no gaps or unexplained overlaps in

the responsibilities of those personnel concerned

with the application of Good Manufacturing Practice

Responsibilities of the

Head of the Production Department

• to ensure that products are produced and stored

####### according to the appropriate documentation in order

####### to obtain the required quality

• to approve the instructions relating to production

####### operations and to ensure their strict implementation

Responsibilities of the

Head of the Production Department

• to ensure that the production records are evaluated

####### and signed by an authorized person before they are

####### sent to the Quality Control Department

• to check the maintenance of his department,

####### premises and equipment

Responsibilities of the

Head of Quality Control Department

• to approve or reject, as

####### he sees fit, starting

####### materials, packaging

####### materials, and

####### intermediate, bulk and

####### finished products

• to evaluate batch

####### records

• to ensure that all

####### necessary testing is

####### carried out

Responsibilities of the

Head of Quality Control Department

• to approve specifications,
  sampling instructions,
  test methods and other
  Quality Control
  procedures
• to approve and monitor
  any contract analysts
• to check the maintenance
  of his department,
  premises and equipment

Joint Responsibility

• the authorization of written procedures and other
  documents, including amendments
• the monitoring and control of the manufacturing
  environment
• plant hygiene
• process validation
• training
• the approval and
  monitoring of suppliers of materials

Joint Responsibility

• the approval and

####### monitoring of contract

####### manufacturers

• the designation and

####### monitoring of storage

####### conditions for materials

####### and products

• the retention of records

TRAINING

TRAINED PERSONNEL=QUALITY PERFORMANCE

=CONTINUAL IMPROVEMENT

####### LESS PRONE TO ERRORS

####### LESS DEVIATIONS FROM STANDARDS

####### REDUCE AMOUNT OF REWORK

####### REDUCE AMOUNT OF REJECTS

Training

• The manufacturer should provide training for all the

####### personnel whose duties take them into production

####### 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