Production 1

Module details

Title

Production 1

Type

Rotation

Module code

SPE202

Credits

10

Requirement

Compulsory

Aim of this module

This rotation introduces trainees to manufacturing and production procedures and will enable them to gain skills and experience in manufacturing and production, from the development of a safe new product through the manufacturing process to storage and distribution. Trainees will gain experience through observation, assisting with or performing a range of routine procedures in the context of providing high-quality safe medicines used in the treatment of a range of patients and will be expected to develop and build their professional practice.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1	Competency Select an appropriate production method for a new product	Action View
# 2	Learning outcome 1	Competency Design a label in accordance with the requirements for labelling medicinal products	Action View
# 3	Learning outcome 1	Competency Identify all equipment that would be required to manufacture a particular product	Action View
# 5	Learning outcome 1	Competency Select appropriate container/closure system for new product	Action View
# 6	Learning outcome 2	Competency Assist in the manufacture of a variety of products, including solutions, creams (emulsions), ointments, suppositories, tablets, capsules and suspensions, dependent on the facilities and range of products available on site	Action View
# 7	Learning outcome 2	Competency Manipulate a range of active pharmaceutical ingredients in a range of dosage forms, including the use of common excipients	Action View
# 8	Learning outcome 2	Competency Assist in the operation of a range of various pieces of pharmaceutical manufacturing equipment	Action View
# 9	Learning outcome 2	Competency Assist in the receipt, storage and issue of raw materials, packaging components and labels	Action View
# 10	Learning outcome 2	Competency Generate labels correctly, carry out line clearances and correctly label products	Action View
# 11	Learning outcome 2	Competency Perform the visual inspection of products	Action View
# 12	Learning outcome 2	Competency Collect water appropriately for use in pharmaceutical manufacturing	Action View
# 13	Learning outcome 2	Competency Assist in the cleaning of equipment and facilities	Action View
# 14	Learning outcome 2	Competency Assist in the preparation of a variety of components/containers/closures prior to use in manufacture	Action View
# 15	Learning outcome 2	Competency Assist in the cleaning, monitoring and review of documentation with respect to sterilising equipment	Action View
# 16	Learning outcome 2	Competency Observe and assist in performing planned preventative maintenance (PPM)	Action View
# 17	Learning outcome 2	Competency Observe the process for determining any actions to be taken before returning equipment to use following servicing and assist in this process	Action View
# 18	Learning outcome 3	Competency Assist in product distribution and sales, monitoring of the disposal of out-of-date stock	Action View
# 19	Learning outcome 3	Competency Observe the management of raw material and finished product inventories	Action View
# 20	Learning outcome 3	Competency Undertake a stock check on starting materials and finished products and work through the process for returning a product into stock	Action View
# 21	Learning outcome 3	Competency Deal with receipt or dispatch of cold chain items	Action View
# 22	Learning outcome 4	Competency Place a batch in quarantine Observe the checks required on systems, pharmaceutical water and environment prior to product release	Action View
# 23	Learning outcome 4	Competency Assist in process validation, monitoring and testing in accordance with procedure	Action View
# 24	Learning outcome 4	Competency Assist/write investigation report for discussion and dissemination	Action View
# 4	Learning outcome 1	Competency Assist in writing/reviewing the standard operating procedure/batch manufacturing record	Action View

Assessments

You must complete:

• 1 case-based discussion(s)
• 1 of the following DOPS/ OCEs:

Assemble materials in accordance with a batch manufacturing procedure	DOPS
Demonstrate correct usage of an item of equipment from this list autoclaves dry heat sterilising ovens, filling machines, filter integrity testers mixers capping machines equipment used for the preparation of containers and balances	DOPS
Demonstrate use of in process controls	DOPS
Monitor sterilisation logs	DOPS
Validate and use a cleaning procedures	DOPS
Observe the inspection storage and quarantine of products	DOPS
Demonstrate the process of water purification and storag	DOPS
Explain the clinical uses of a range products	OCE
Explain to a clinical colleague why a defective product cannot be released for clinical use	OCE

Learning outcomes

1. Apply the principles of EU Good Manufacturing Practice to develop a safe new product and assess the scope of the licence held by the organisation when considering a new product .
2. Observe, assist and where appropriate perform, under supervision, a range of processes and procedures in accordance with local practice in order to manufacture products safely (This includes the clothing requirements and handling of waste. The range of equipment used may include autoclaves, dry heat sterilising ovens, filling machines, filter integrity testers, mixers, capping machines, equipment used for the preparation of containers and balances).
3. Perform a range of activities to support safe storage and distribution of medicinal products.
4. Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice and pharmaceutical management quality systems.

Learning outcomes

1. Discuss the role of the Clinical Scientist in Clinical Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture and quality control with reference to key patient care pathways. 
2. Describe the principles of pharmaceutical formulation and processing
3. Describe the properties of excipients and ingredients in pharmaceutical products
4. Explain the factors affecting formulation, stability and preservation of pharmaceutical product
5. Perform mathematical calculations relevant to pharmaceutical formulation
6. Describe the principles of sterilisation
7. Understand the criticality of final packaging

Indicative content

Clinical Pharmaceutical Science in key patient and care pathways

• Diagnosis using radioactive materials
• Treatment relevant to the patient and care pathway, including chemotherapy
• Treatment using radioactive materials
• The role of regulation, Good Manufacturing Practice, aseptic techniques and quality assurance in ensuring patient safety

Pharmaceutical formulation and processing

• Sources, preparation and purification of major drug substances and excipients
• Formulation
• Stability studies
• Drug administration systems
• Analytical method development
• Specification development
• Presentation of the product in relation to its method of use and/or administration
• Equipment calibration
• Rational approach to process validation

Principles of formulation

• Solutions, topical liquids
• Semi-solids, creams and ointments,
• Injections, including parenteral infusions, e.g. nutrition mixtures
• Tablets, capsules, cachets
• Specialised dose forms for medicinal purposes (powders, depot products, inhalation products, transdermal products)
• Extemporaneous preparation

Properties of excipients and ingredients in pharmaceutical products

• Thickeners, sweeteners, buffers, tonicity adjusters,  preservatives, flavours and stabilisers

Principles of rheology (viscosity and fluid flow)

Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products

• Solubility, dissolution
• Ionisation, deionisation of water, conductivity
• pH and acid-base reactions
• Precipitation, salting out, flocculation
• Complexation,
• Redox reactions (oxidation, reduction, redox potentials)
• Partitioning, phase separation
• Thermal issues, boiling point, melting point, volatilisation/vapours
• Thermolabile degradation/effects of temperature,

Criticality of final packaging

• Container types and closures
• Factors relevant to product protection
• Labelling

Mathematical principles and calculations for pharmaceutical sciences

• Buffering and related calculations
• Dilutions and dose adjustments
• Tonicity adjustments

Miscellaneous

• Principles of drug absorption and uptake
• Transport across membranes
• Principles of compounding parenteral nutrition mixtures

Activities

• Observe the use of a range of products manufactured by the unit (and other specials units) and discuss the process for obtaining and using these products, which in many cases may be unlicensed specials, with staff and patients, including their concerns about safety
• Observe the work of the production and manufacturing staff and discuss the awareness of the requirement to meet defined specifications for manufactured products and classes of product
• Observe the work of the development, production and manufacturing staff and discuss the factors involved in the development of new products, considering formulation, manufacturing method, process validation, in-process and final product testing, and product storage and distribution with your training officer
• Discuss the maintenance, validation and revalidation requirements of equipment used in the manufacture of pharmaceutical products with your training officer
• Use a range of the key reference texts such as Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Aulton, Pharmaceutical Codex, older editions of Martindale (such as 27th edn), Health Technical Memorandum 2010, etc, and critique the strengths and limitations of each resource
• Discuss how a pharmaceutical quality management system is used to ensure and improve the quality of manufactured products with your training officer
• Attend internal departmental meetings where the quality management system/change control/deviations, etc, are discussed and evaluate the role of shared experience and team working to ensure the continual development of clinical pharmaceutical science and patient safety