R&R: Technical service records in hospital pharmacy

Record description

Full records of each product batch from materials, process, checks to results of product tests.

Minimum retention period

• 10 years for adult records
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended

Reasoning for retention advice

GMP advises keeping records for 1 year after expiry of the batch or at least 5 years after certification of the batch by the Qualified Person, whichever is longer.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

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

Record description

Full records of each product batch from materials, process, checks to results of product tests.

Minimum retention period

• 10 years for adult records
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended

Reasoning for retention advice

GMP advises keeping records for 1 year after expiry of the batch or at least 5 years after certification of the batch by the Qualified Person, whichever is longer.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

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

Record description

Full records of each product batch from materials, process, checks to results of product tests.

Minimum retention period

• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended

Reasoning for retention advice

GMP advises keeping records for 1 year after expiry of the batch or at least 5 years after certification of the batch by the Qualified Person, whichever is longer.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

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

Record description

Records of cleaning and disinfection of the production unit.

Minimum retention period

• 1 year after expiry date of batch or
• 3 years after batch distribution where the ingredients has retest dates

Reasoning for retention advice

GMP advises all production records should be kept for at least 1 year after expiry date.

For active pharmaceutical ingredients with retest dates, records should be kept for at least 3 years after the batch has been completely distributed.

Record description

Records of errors, investigations and corrective actions.

Minimum retention period

• 10 years for adult records.
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended.

Reasoning for retention advice

These records must be available for inspection and linked to product history under GMP.

It is likely that these records are linked to a batch so batch documentation rationale applies.

Record description

Cleanroom and clear air device monitoring data such as air, microbiology and temperature.

Minimum retention period

• 1 year after the expiry date of the batch or
• 5 years after the certification of the batch by the Qualified Person, whichever is longer

Reasoning for retention advice

Based on GMP advice.

Record description

Records of equipment maintenance such as cleaning, servicing and what batches have been processed.

Minimum retention period

• 11 years

Reasoning for retention advice

Based on RMCoP advice.

Record description

Full records of each batch from materials, process, checks to results of product tests.

Minimum retention period

• 10 years for adult records.
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended.

Reasoning for retention advice

GMP advises keeping records for 1 year after expiry of the batch or at least 5 years after certification of the batch by the Qualified Person, whichever is longer.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

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

General Pharmaceutical Council (GPhC) advise keeping for as long as you consider necessary incorporating consumer protection.

Record description

Full records of each batch from materials, process, checks to results of product tests.

Minimum retention period

• 10 years for adult records
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended

Reasoning for retention advice

GMP advises keeping records for at least 5 years after completion or formal discontinuation of the clinical trial in which the batch was used.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

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

Record description

Full records of each batch from materials, process, checks to results of product tests.

Minimum retention period

• 30 years after the expiry of the medicine

Reasoning for retention advice

Based on GMP advice.

Record description

SME to advise

Minimum retention period

• SME to advise

Reasoning for retention advice

SME to advise

Record description

Records record for a single patient-specific aseptic preparation.

Minimum retention period

• 10 years for adult records
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended

Reasoning for retention advice

GMP advises all production records should be kept for at least 1 year after expiry date.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

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

Record description

Records of analytical and microbiology results, certificates of analysis and batch release decisions.

Minimum retention period

• 1 year after batch expiry date or 5 years after certification
• 10 years for consumer protection

Reasoning for retention advice

GMP advises keeping for 1 year after the expiry date or at least 5 years after certification, whichever is longer.

GMP advises keeping records for at least 5 years after completion or formal discontinuation of the clinical trial in which the batch was used.

CPA 1982 advises keeping records for up to 10 years for adult and children records.

Record description

Full records for batch production which includes raw materials, equipment used, cleaning, processing, labelling, packaging and finished product.

Records for validation and commissioning of the plant.

Minimum retention period

• 10 years for adult records
• 25 years for children’s records or until their 26^th birthday if the child was 17 years old when their treatment ended
• 5 years after the last product release for plant validation and commissioning records

Reasoning for retention advice

GMP advises keeping batch records for 3 years.

CPA 1982 advises keeping batch records for up to 10 years for adult and children records.

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

GMP advises keeping plant records for 1 year after the expiry date or at least 5 years after the release of the last product processed by the plant, whichever is longer.

Record description

A controlled checklist or record confirming the availability, integrity, and readiness of critical medicines.

Minimum retention period

• 1 year after expiry of longest data item
• 10 years for consumer protection

Reasoning for retention advice

There are no batch manufacturing records.

Record description

Training logs and aseptic competency records.

Minimum retention period

• 6 years from the end of employment for clinical training records or until 75^th birthday, whichever is longer
• 10 years from training completion for statutory and mandatory training

Reasoning for retention advice

RMCoP advises training records other than clinical, statutory and mandatory training should be kept for 6 years from the end of employment.