Prepare documentation and materials for the production of aseptic products
Overview
This standard covers the generation of documentation and preparation of starting materials, components and other consumables necessary for the production of aseptic products. It covers preparation of documentation for both dispensing and manufacturing.
Your practice will be consistent with your occupational role and carried out under the regulatory, professional and ethical frameworks established in the context of current legislation. You will need to take a reflective approach to your work.
You will work at all times within Standard Operating Procedures that relate to the way in which a pharmacy service is provided in your place of work. A caring and compassionate approach should be adopted in line with current healthcare guidance. Users of this standard will need to ensure that practice reflects up to date information and policies.
Performance criteria
You must be able to:
- work within the relevant Standard Operating Procedures including the relevant health and safety procedures and within your own limits of competence
- put on the appropriate clothing relevant to the area of work, following the correct procedure
- ensure that the environmental areas have been cleaned using the correct equipment and materials
- ensure that the work area is always clean and tidy
- ensure that you work using the correct prescription / order
- confirm you have the correct documentation for the product, completing any calculations as appropriate
- generate the relevant documentation according to local guidelines and protocols
- generate the labels and ensure that all labels produced are accounted for and complete, accurate and legible
- allocate the batch number and expiry date for the product
- ensure that the relevant environmental parameters are within the set limits
- select the correct starting materials and equipment for the product, recording the relevant information on the correct documentation
- confirm the starting materials and equipment are fit for purpose
- ensure that the appropriate in-process checks have been carried out by the relevant person
- record and report any near misses or errors in line with organisational procedures
- feedback any near misses or errors to colleagues to minimise potential future errors
- make clear and accurate entries on all the relevant documentation
- disinfect the starting materials and equipment for transfer into the clean room
- act within the limits of your authority and refer any problems to an appropriate person
- complete all relevant documentation and store appropriately in accordance with legal and organisational requirements
Knowledge and Understanding
You need to know and understand:
- the Standard Operating Procedures and the importance of adhering to them at all times
- the importance of working within the limits of your competence and authority, when to seek agreement or permission from others and when to refer on to an appropriate person
- current health and safety legislation and how it applies to the working environment
- legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being carried out
- the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed
- the importance of adhering to information governance policies and maintaining confidentiality when sharing information about individuals with others
- the duty to report any acts or omissions that could be detrimental to individuals, yourself, colleagues or your employer
- the principles of good manufacturing practice, including pharmaceutical quality systems and your role within that
- the difference between preparation for individual patients and preparation for stock and how this is generally implemented in the workplace
- the recognised guidelines relating to aseptic preparation
- the importance of maintaining a clean working environment
- the importance of personal hygiene and the correct use of protective / clean room clothing
- the different types of environmentally controlled areas and when they should be used
- the possible sources of contamination and appropriate methods of prevention
- the materials and equipment necessary for the preparation of aseptic production
- the principles of formulae calculations, weights and measures
- the importance of environmental parameters, how to carry out their monitoring and the referral procedures if they are outside the set limits
- the various types of products
- chemical and physical properties of ingredients relevant to formulation and compounding, including any interactions between raw materials and components
- labelling and packaging requirements and conventions
- aseptic techniques and when to use the different processes to minimise any associated risks
- the procedures for cleaning, decontamination, and preparing the environment and components
- the importance of carrying out accuracy and quality checks
- the importance of using approved documentation
- how to identify near misses and errors
- the causes and consequences of near misses and errors
- local and/or national error reporting procedures and communication channels
- the importance of recording, storing and retrieving information in accordance with organisational procedures
Scope/range
Scope Performance
Scope Knowledge
Values
Behaviours
Skills
Glossary
Links To Other NOS
External Links
This standard links with the following dimension within the NHS Knowledge and Skills Framework (October 2004):
Dimension: HWB10 Products to meet health and wellbeing needs