This document discusses quality assurance and good manufacturing practices. It defines quality and quality assurance, and describes their importance in ensuring products meet specified requirements. It outlines principles of good manufacturing practice (GMP) that systems must follow to consistently produce products according to quality standards. Responsibilities of key roles like production managers, quality control heads, and authorized persons are also summarized.

2.  QUALITY
 QUALITY ASSURANCE
 JOB RESPONSIBILITIES
 GOOD MANUFACTURING PRACTICE
 PRINCIPLES OF GMP
 RESPONSIBILITIES
 PRODUCTION MANAGER
 QUALITY CONTROL HEAD
 RESPONSIBILITIES OF AUTHORIZED PERSON

3.  Quality is the degree to which an object or entity (e.g., process, product, or
service) satisfies a specified set of attributes or requirements. The quality of
something can be determined by comparing a set of inherent characteristics with a
set of requirements.

4. Quality assurance (QA) is any systematic process of determining whether a
product or service meets specified requirements. QA establishes and maintains
set requirements for developing or manufacturing reliable products.
Examples of quality assurance activities include process checklists, process
standards, process documentation and project audit.

5.  Harmonization of (Global) Quality Management Systems
 Gap Analyses of the Q-Manuals against relevant Guidelines and Regulations
 Developing and implementing QMS (Policies/SOPs) improvements of our clients
 Review and correction of SOP landscapes
 Writing of Global Quality Standards
 Ensure complied documentation systems of our clients
 Writing Quality risk management (QRM) concepts with the corresponding SOPs,
templates and tools
 Conception and Implementation of Supplier Quality Agreements

6. Good Manufacturing Practice (GMP) is a system for ensuring that products are
consistently produced and controlled according to quality standards.
GMP covers all aspects of production from the starting materials, premises, and
equipment to the training and personal hygiene of staff. Detailed written procedures are
essential for each process that could affect the quality of the finished product.

7. Principle 1
 Personnel Qualifications
This includes training, education and experience for the specific job being
performed.
Principle 2
 Testing and Approval or Rejection of Components, Drug Product Containers,
and Closures
This includes supplier and quality agreements, user specifications, incoming testing
and proper storage for use.
Principle 3
 Sampling and Testing of In-Process Materials and Drug Products
Validation is performed to ensure that when processes are followed the same way
each time the product consistently meet specifications.

8. Principle 4
 Packaging and Labeling Operations
The facility must be maintained to ensure the environment does not contribute to
adulteration of the drug product, this includes contamination, cross-contamination
or temperature/humidity which may effect product. This also includes lighting and
water.
Principle 5
 Responsibilities of Quality Control Unit
Incoming, in process, and finished product testing work together to ensure the
product purports to have the established characteristics throughout the
manufacturing process.
Principle 6
 Expiration Dating
Stability testing and review of retains should ensure that the drug product maintains
its characteristics throughout the expiry period (until the expiration date)

9.  The preparation of the companies QA manual control and supervision of all
amendments and revisions
 Monitor all quality related activities on the project
 Coordinate all QA/QC activities with the site QC manager
 Coordinate all QA/QC activities with the site QA/QC procurement manager
 Control and the distribution of all the companies quality documentation
 Coordinate all quality related correspondence with the customers representatives.
 Monitor statistical method reporting.

11.  A Production Manager is a professional who oversees the production process and
coordinates all activities to ensure enough resources on hand.
 They can plan workers' schedules, estimate costs and prepare budgets to ensure
workflow meets required deadlines.
 Estimate costs and prepare budgets Organize workflow to meet specifications and
deadlines
 Monitor production to resolve issues ,
 Supervise and evaluate performance of production personnel (quality inspectors,
workers etc.)Determine amount of necessary resources (workforce, raw materials
etc.)Approve maintenance work, purchasing of equipment etc.
 Ensure output meets quality standards
 Enforce health and safety precautions
 Report to upper management

12.  The heads of Production, Quality Control and where relevant, Head of Quality
Assurance or Head of Quality Unit, generally have some shared, or jointly
exercised, responsibilities relating to quality including in particular the design,
effective implementation, monitoring and maintenance of the quality
management system.
 The authorisation 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;
 The approval and monitoring of contract manufacturers and providers of other
GMP related outsourced activities;

13.  A QC analyst performs various scientific analyses to evaluate the quality of raw
materials, in-process materials, and finished goods and ensure compliance with
established standards. Conducts and validates various biological and chemical
quality control (QC) assays.
 Compiles, interprets, and documents statistical data from testing processes to either
confirm compliance with established quality standards or identify deviations. They
are maybe responsible for establishing specifications for conducting assays and
writing standard operating procedures.
 Evaluation of batch records. This should be done as part of the product release
process.
 The purpose is to be reassured that products have been produced in accordance
with the agreed process, and meets specifications.


14.  Batch review and decision making on disposition; including deviation evaluation and close-out
 GMP Agreements and auditing in contract giving and acceptance
 Process Control Plans and Quality System processes (including risk assessment tools)
 Stability and validation status of product being released
 The authorized person will also be involved in other activities,Including the following:
 implementation (and, when needed, establishment) of the quality system;
 participation in the development of the company
 quality manual;

15.  Approving a batch for release should always ensure that the following requirements
have been met:
 The marketing authorization and the manufacturing authorization requirements for
the product have been met.
 The principal manufacturing and testing processes have been validated
 All the necessary checks and tests have been performed and account taken of the
production conditions and manufacturing records;