Back Module: S-PS-R4

Introduction to Production and Quality Control

Module information

Module details

Title
Introduction to Production and Quality Control
Type
Rotation
Module code
S-PS-R4
Credits
10
Phase
1
Requirement
Compulsory

Aim of this module

This rotation will introduce trainees to principles and practices of manufacture of pharmaceutical products. Trainees will appreciate the range of products and the application in patient care. Trainees will be introduced to the roles and responsibilities of the multidisciplinary team working in a production unit and regulation which guides the process of preparing products.

Trainees will also be introduced to a variety of analytical techniques used in the quality control testing of pharmaceutical products and in monitoring the cleanrooms used for manufacture and preparation.

Work-based content

Training activities

# Learning outcome Training activity Type Action
# 1 Learning outcome 1,2,3,6 Training activities

Attend a meeting between Production and QC teams and reflect on the meeting

 Type OTA Action View
# 2 Learning outcome 1,2,3,6 Training activities

Shadow the Production Operators and reflect on their role

 Type OTA Action View
# 3 Learning outcome 1,2,3,6 Training activities

Shadow a Quality Control Analyst and reflect on their role

 Type OTA Action View
# 4 Learning outcome 1,2,3,6 Training activities

Observe chemical and microbiological testing of starting materials and reflect on the process

 Type OTA Action View
# 5 Learning outcome 1,2,3,6 Training activities

Observe chemical and microbiological testing of final products and reflect on the process

 Type OTA Action View
# 6 Learning outcome 1,2,3,6 Training activities

Follow a product through manufacture and quality control to receipt by a customer and administration to a patient and reflect on the product journey

 Type OTA Action View
# 7 Learning outcome 1,3,4,6 Training activities

Explore a current clinical trial involving manufacture of products and reflect on the impact this will have on practice

 Type OTA Action View
# 8 Learning outcome 1,3,5,6 Training activities

Review the effect of good practice (GXP) guidance on production and QC and reflect on how this guides practice

 Type OTA Action View
# 9 Learning outcome 1,2,3,6 Training activities

Observe the manufacture of two dosage forms and reflect on the process

 Type OTA Action View
# 10 Learning outcome 1,2,3,6 Training activities

Attend a team meeting and reflect for:

  • Production
  • QC
 Type OTA Action View

Assessments

Complete 1 Case-Based Discussion

Complete 1 DOPS or OCE

Direct Observation of Practical Skills Titles

  • Perform handwashing and gowning to enter the cleanroom.
  • Perform an internal competence test on an analytical technique.

Observed Clinical Event Titles

  • Describe a production exception and its impact on the product quality.
  • Describe a QC exception and its impact on the product quality.

Learning outcomes

# Learning outcome
1

Explore the contribution of the Clinical Pharmacy Production Unit and Quality Control Laboratory to patient care.
2

Identify the roles and relationships of the multidisciplinary team in the Clinical Pharmacy Production Unit and Quality Control Laboratory.
3

Describe the working practices of the Clinical Pharmacy Production Unit and Quality Control Laboratory.
4

Examine the impact of innovation in the Clinical Pharmacy Production Unit.
5

Review the effect of legislation in the Clinical Pharmacy Production Unit.
6

Compare and contrast the practices in the Clinical Pharmacy Production Unit and Quality Control Laboratory with other areas of Pharmaceutical Sciences.

Clinical experiences

Activities

Information:

There is no clinical experiential learning associated with this module.

Academic content (MSc in Clinical Science)

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning outcomes

On successful completion of this module the trainee will be able to:

  1. Describe the stages of the manufacturing process of various product types.
  2. Apply integrative knowledge of the principles of sterilisation by irradiation, filtration, gas, moist and dry heat.
  3. Describe the principles of quality assurance in relation to pharmaceutical production.
  4. Critically evaluate the routine analytical techniques used in quality control of pharmaceuticals.
  5. Demonstrate a critical awareness of the process for defining a test specification.
  6. Describe the role of the QC (MGPS) in testing piped medical gas systems.

Indicative content

Production

Selection of starting materials (including WFI)

Selection and preparation of packaging components.

  • Weighing
  • Measuring
  • Milling
  • Mixing
  • Filtration
  • Filling
  • Sealing
  • Labelling
  • Sterilisation
    • HTM 2010
    • Irradiation
    • Filtration
    • Gas
    • Moist heat
    • Dry heat
  • Inspection
  • Sampling
  • Quarantine
  • Release
  • Storage and distribution

Quality Control

  • Piped medical gas systems
    • HTM 02
    • Role of the QC (MGPS)
    • Range of gases
  • Manufactured products
    • Routine release
    • Ongoing stability
    • Mixing trial validations
    • Stability studies
  • Aseptic products
    • Stability studies
    • Sterility testing
    • EM
    • Chemical testing

Specifications and practical application

Introduction to analytical techniques

  • Chemical
  • Microbiological

Module assigned to

Specialties

Specialty code Specialty title Action
Specialty code SPE2-1-22 Specialty title Pharmaceutical Science [2022] Action View
Specialty code SPE2-1-23 Specialty title Pharmaceutical Science [2023] Action View
Specialty code SPE2-1-24 Specialty title Pharmaceutical Science [2024] Action View
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