Prepare documentation and materials for the production of aseptic products

URN: SFHPHARM21
Business Sectors (Suites): Pharmacy
Developed by: Skills for Health
Approved on: 2016

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:

  1. work within the relevant Standard Operating Procedures including the relevant health and safety procedures and within your own limits of competence
  2. put on the appropriate clothing relevant to the area of work, following the correct procedure
  3. ensure that the environmental areas have been cleaned using the correct equipment and materials
  4. ensure that the work area is always clean and tidy
  5. ensure that you work using the correct prescription / order
  6. confirm you have the correct documentation for the product, completing any calculations as appropriate
  7. generate the relevant documentation according to local guidelines and protocols
  8. generate the labels and ensure that all labels produced are accounted for and complete, accurate and legible
  9. allocate the batch number and expiry date for the product
  10. ensure that the relevant environmental parameters are within the set limits
  11. select the correct starting materials and equipment for the product, recording the relevant information on the correct documentation
  12. confirm the starting materials and equipment are fit for purpose 
  13. ensure that the appropriate in-process checks have been carried out by the relevant person
  14. record and report any near misses or errors in line with organisational procedures
  15. feedback any near misses or errors to colleagues to minimise potential future errors
  16. make clear and accurate entries on all the relevant documentation
  17. disinfect the starting materials and equipment for transfer into the clean room
  18. act within the limits of your authority and refer any problems to an appropriate person
  19. complete all relevant documentation and store appropriately in accordance with legal and organisational requirements

Knowledge and Understanding

You need to know and understand:

  1. the Standard Operating Procedures and the importance of adhering to them at all times
  2. 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
  3. current health and safety legislation and how it applies to the working environment
  4. legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being carried out
  5. the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed
  6. the importance of adhering to information governance policies and maintaining confidentiality when sharing information about individuals with others
  7. the duty to report any acts or omissions that could be detrimental to individuals, yourself, colleagues or your employer
  8. the principles of good manufacturing practice, including pharmaceutical quality systems and your role within that
  9. the difference between preparation for individual patients and preparation for stock and how this is generally implemented in the workplace
  10. the recognised guidelines relating to aseptic preparation
  11. the importance of maintaining a clean working environment
  12. the importance of personal hygiene and the correct use of protective / clean room clothing
  13. the different types of environmentally controlled areas and when they should be used
  14. the possible sources of contamination and appropriate methods of prevention
  15. the materials and equipment necessary for the preparation of aseptic production
  16. the principles of formulae calculations, weights and measures
  17. the importance of environmental parameters, how to carry  out their monitoring and the referral procedures if they are outside the set limits
  18. the various types of products
  19. chemical and physical properties of ingredients relevant to formulation and compounding, including any interactions between raw materials and components
  20. labelling and packaging requirements and conventions
  21. aseptic techniques and when to use the different processes to minimise any associated risks
  22. the procedures for cleaning, decontamination, and preparing the environment and components
  23. the importance of carrying out accuracy and quality checks
  24. the importance of using approved documentation
  25. how to identify near misses and errors
  26. the causes and consequences of near misses and errors
  27. local and/or national error reporting procedures and communication channels
  28. 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


Version Number

2

Indicative Review Date

2021

Validity

Current

Status

Original

Originating Organisation

Skills for Health

Original URN

SFHPHARM21

Relevant Occupations

Health Associate Professionals, Health Professionals

SOC Code

2251

Keywords

Aseptic; dispensing; manufacturing; preparation; pharmacy; production