Study-Unit Description

Study-Unit Description


CODE PHR2604

 
TITLE Pharmaceutical Quality Control

 
LEVEL 02 - Years 2, 3 in Modular Undergraduate Course

 
ECTS CREDITS 4

 
DEPARTMENT Pharmacy

 
DESCRIPTION This study-unit is concerned with the part of Good Manufacturing Practice within the laboratory and all other steps involved that ensure the quality of the pharmaceutical products.

General concepts of Good quality control laboratory practice:

- Pharmaceutical Quality
- Good Manufacturing Practice
- Good Laboratory Practice
- Health & Safety considerations
- The differences and interplay between GMP and GLP
- The function of the Quality Control Laboratory
- Premises
- Legislation and Guidance Documents

Personnel
- Organogram
- Staffing
- Delegation of duties
- Training needs and Training matrix

Documentation
- Specifications
- Material Safety Data Sheets
- Standard operating procedures with special reference to:
    - Testing procedures and records (including worksheets, laboratory notebooks and equipment logbook maintenance)
    - Accountability
    - Analytical reports, certificates
    - Environmental monitoring and data handling
    - Validation records of test methods
    - Calibration of instruments
    - Maintenance of equipment (Preventive and remedial)
- Deviations, Incidents and change control procedures

Sampling
- Equipment for sampling
- Sample size and methodologies to follow
- Sample container and identification tags
- Precautions and identifying sources of error
- Specific sampling issues related to various substances / dosage forms, including; Active Pharmaceutical Ingredients (API), solid oral dosage forms, emulsions, parenteral fluids, medical gases, cytotoxics, radio pharmaceuticals, gene therapy
- Storage conditions and stock rotation of materials
- Cleaning and storage of test equipment

Testing
- Premises- Laboratory design and flow of work
- Application of documentation practices with respect to testing
- Validation processes – Validation Master Plan
- Automated equipment and validation criteria
- Result handling / data processing
- Authorisations
- Reference and secondary standards
- Reagents
- In-process controls
- Contracting out work to third party laboratories

On-going stability testing
- Product life-cycle
- Stability testing and obligations
- Stability chambers and their validation
- Importance and implication of data obtained

Study-unit Aims

To familiarise students with the Quality Control Part of the Pharmaceutical Manufacture Process, with references to Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).

Learning Outcomes

1. Knowledge & Understanding:

By the end of the study-unit the student will be able to interpret guidelines on GLP and GMP with regards to quality control.

2. Skills:

By the end of the study-unit the student will be able to:
- Appreciate the importance of Good Manufacturing Practice principles within a quality system.
- Understand better the importance of validation and the negative effects of uncontrolled changes to a system.
- Follow Standard Operating Procedures related to quality control.
- Develop Standard Operating Procedures for processes in quality control.
- Maintain documentation required in quality control.

Main Text/s and any supplementary readings

- European Pharmacopoeia – Sixth Edition
- EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines (current edition)
- MHRA. Rules and Guidance for Pharmaceutical Manufacturers and Distributors. London: Pharmaceutical Press; 2007.
- Sharp J. Quality in the Manufacture of Medicines and other Healthcare Products. London: Pharmaceutical Press; 2000.

 
STUDY-UNIT TYPE Lecture

 
METHOD OF ASSESSMENT
Assessment Component/s Assessment Due Resit Availability Weighting
Online Examination (2 Hours) SEM2 Yes 100%

 
LECTURER/S Dustin Balzan
Lilian Wismayer

 
The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints.
Units not attracting a sufficient number of registrations may be withdrawn without notice.
It should be noted that all the information in the description above applies to study-units available during the academic year 2020/1. It may be subject to change in subsequent years.

https://www.um.edu.mt/course/studyunit