Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 5 years.

Provenance

In accordance with Good Distribution Practice (GDP).

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP / GDP / GPhC requirements.

Minimum period

Retain for 1 year or longer for sites holding a WDA Wholesale Dealers Licence.

Comment

Refrigerator records to be kept for the life of any product stored in them – particularly vaccines. For sites subject to GDP inspection (licensed wholesaler), records should be kept for 5 years as with other GDP records. SOPs detailing actions required in the event of fridge failure should also be available.

Other Regulators may also request access to temperature records.

Provenance

In accordance with the Guide on Good Distribution Practice (part of the Orange Guide).

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 6 complete tax years.

Comment

The 6-tax-years limit relates to disputes over simple contract (Limitation Act 1980). Manufacturers, and sometimes others involved in a product’s supply chain, are liable for their products under the Consumer Protection Act 1987. Therefore, it is recommended to keep delivery notes or invoices for 11 years as product liability records.

Provenance

Limitation Act 1980. Chapter 58.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

Current financial year plus 1.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference.

Minimum period

Retain for 3 months.

Comment

Allow a “reasonable” period of time for verification of the order. This should be locally determined.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

To demonstrate compliance with Good Distribution Practice (GDP).

Minimum period

Retain for 5 years.

Provenance

In accordance with the Guide on Good Distribution Practice (part of the Orange Guide).

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 11 years.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 1 year.

Provenance

SPS Quality Assurance recommended good practice.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with Good Distribution Practice (GDP) and for audit purposes.

Minimum period

Retain until the vaccine expiry date, plus 12 months.

Comment

The Green book, July 2022, Chapter 3 says “Temperatures in the refrigerator must be monitored and recorded at least once each working day, and documented on a chart for recording temperatures. An example can be found on page 36. The records should be readily accessible, be retained for at least one year, and cover the full storage history of any products contained in the fridge.

As shelf lives specified by vaccine manufacturers can be up to four years or longer, retaining records for five years will generally enable the full storage history of the vaccines be accounted for.”

Provenance

Community Pharmacy Seasonal Influenza Vaccine Service

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 6 months.

Comment

Patient’s own drugs can be removed and/or disposed of with the agreement of the patient or in the interest of the patient/general safety.

Provenance

Professional guidance on the safe and secure handling of medicines. RPS, December 2018.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 3 years.

Provenance

Department of Health. Safe management of healthcare waste. Version 2.0. England. May 2012.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years.

Provenance

Department of Health. Safe management of healthcare waste. Version 2.0. England. May 2012.