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Technical service records in hospital pharmacy

Last updated See all updates
Topics: Record keeping

Recommendations on the retention of records relating to aseptic preparation, manufacturing and technical services within hospital pharmacy.

This article forms part of a series
  1. Retaining and storing pharmacy records in England
    1. Additional services records in community pharmacy
    2. Clinical governance and patient safety records in pharmacy
    3. Clinical trial records in hospital pharmacy
    4. Controlled Drugs (CD) records in pharmacy
    5. Prescription and dispensing records in community pharmacy
    6. Prescription and dispensing records in hospital pharmacy
    7. Stock management, waste and recall records in pharmacy
    8. Supply and distribution records in pharmacy
    9. Technical service records in hospital pharmacy

Contents

  1. Using our advice
  2. Specific records
    1. Aseptic worksheets - Section 10
    2. Cleaning logs
    3. Environmental monitoring results
    4. Extemporaneous dispensing
    5. Medical gas pipeline system
    6. Quality control documentation
  4. Update history

Using our advice

Technical services records provide evidence of how medicine products were prepared, checked, released and supplied. These records support product traceability, patient safety, quality assurance and compliance with Good Manufacturing Practice (GMP).

Many technical services records relate directly to products manufactured or prepared for individual patients. The retention periods in this article mainly reflect minimum retention requirements from the MHRA Guidance for specials manufacturers, GMP, and legislation.

Where multiple retention periods apply, organisations should normally retain records for the longest applicable period. See Retaining and storing pharmacy records in England (SPS page) for factors that may justify longer retention.

Specific records

Record description

Records such as chemotherapy worksheets, parenteral nutrition worksheets and centralised intravenous additive service (CIVAS) worksheets.

Minimum retention time

  • retain records for adults for at least 10 years after release
  • retain records for children for at least 25 years after release or until their 26th birthday if the child was 17 years old when their treatment ended

Supporting source

The MHRA guidance for specials manufacturers advises retaining batch documents for at least 1 year after expiry or 5 years after release, whichever is longer.

The Consumer Protection Act (CPA) 1982 advises keeping records for up to 10 years for adult and children records.

The Records Management Code of Practice (RMCoP) advises keeping children’s records until their 25th birthday. Or until their 26th birthday if the child was 17 years old when their treatment ended.

Record description

Records such as cleaning schedules and logs.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The MHRA guidance for specials manufacturers advises retaining batch documents for at least 1 year after expiry or 5 years after release, whichever is longer.

Record description

Records such as microbiological monitoring, air sampling and particle monitoring.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The MHRA guidance for specials manufacturers advises retaining batch documents for at least 1 year after expiry or 5 years after release, whichever is longer.

Record description

Records covering product formulae, preparation, release, supply and labelling.

Minimum retention time

  • retain records for adults for at least 10 years after release
  • retain records for children for at least 25 years after release or until their 26th birthday if the child was 17 years old when their treatment ended

Supporting source

The MHRA guidance for specials manufacturers advises retaining batch documents for at least 1 year after expiry or 5 years after release, whichever is longer.

The CPA advises keeping records for up to 10 years for adult and children products.

The RMCoP advises keeping children’s records until their 25th birthday. Or until their 26th birthday if the child was 17 years old when their treatment ended.

General Pharmaceutical Council (GPhC) guidance for registered pharmacies preparing unlicensed medicines also requires pharmacies to retain sufficient records to allow the preparation process to be reconstructed in the event of a recall or patient safety incident.

Record description

Records such as authorisations and maintenance records associated with pharmacy-managed activities.

Minimum retention time

  • retain records for the lifetime of the pipeline

Supporting source

The RMCoP advises on the retention of records relating to estates, such as major building works.

Record description

Records such as certificates of analysis, certificates of conformity, and release testing .

Minimum retention time

  • retain records for at least 5 years

Supporting source

The MHRA guidance for specials manufacturers advises retaining batch documents for at least 1 year after expiry or 5 years after release, whichever is longer.

Update history

  1. Republished
  2. Full review and update
  1. Link updated for the Records Management Code of Practice (RMCoP).
  1. Published