Life Sciences & Pharma

Pharmaceutical manufacturer: compliance checklist

A verification checklist for pharmaceutical manufacturers (SIC division 21). Use it to confirm that active-substance registration, the manufacturer's / importer's authorisation with a Qualified Person and GMP, any Home Office controlled-drug licence, the environmental permit for large-scale synthesis and the workplace health-and-safety duties are all in place before a production run.

UK-wide
On this page
UK-wide

Use this checklist to confirm that your pharmaceutical business meets its obligations before a production run. Work through each item and answer yes or no. If you answer no to any item, follow the linked guide for that regime before you proceed. The medicines and controlled-drug regimes apply across the whole United Kingdom, including Northern Ireland; the environmental permit and the workplace safety duties are devolved, so the regulator differs by nation.

MHRA authorisation and registration

Confirm you hold the right MHRA authorisation for what you make.

  1. 1

    Active-substance registration

    If you make, import or distribute active pharmaceutical ingredients, are you registered with the MHRA and working to GMP or Good Distribution Practice for active substances?

  2. 2

    Manufacturer's / importer's authorisation

    If you manufacture, assemble or import finished medicines, do you hold a current MIA from the MHRA, operate to GMP, and pass periodic inspection?

  3. 3

    Qualified Person

    For a finished-product MIA, have you named a Qualified Person who certifies each batch before it is released?

Controlled drugs and environmental permit

Confirm the additional licence and permit are in place where they apply.

  1. 1

    Controlled-drug licence

    If you produce, possess or supply controlled drugs, do you hold a current Home Office controlled-drug licence for the relevant activity, with the required security, registers and standard operating procedures?

  2. 2

    Environmental permit

    If you carry out large-scale chemical synthesis, do you hold a current environmental permit from the Environment Agency, Natural Resources Wales, SEPA or NIEA for your nation?

Workplace health and safety

Confirm the duties that make the site safe to run are met.

  1. 1

    Hazardous substances

    Have you assessed and controlled exposure to active ingredients, solvents, dusts and sensitisers under COSHH, and arranged health surveillance where it is required?

  2. 2

    General health and safety

    Are you meeting your general duty to protect the health, safety and welfare of employees and others affected by the operation?

  3. 3

    Work equipment

    Are your reactors, tabletting and filling lines, mixers and other process equipment suitable, maintained and guarded under PUWER, with operators trained to use them safely?

If you answered no to any item

Do not proceed with a production run until you have closed the gap. For MHRA registration or the MIA, see the guide on getting authorised to manufacture medicines. For the controlled-drug licence, the environmental permit and the site safety duties, see the guide on manufacturing controlled drugs and running a safe pharmaceutical site. If you are unsure which regime applies to what you make, start with the router guide on which medicines manufacturing authorisation applies. If you are unsure whether a regime applies at all, confirm it with the relevant regulator before you commit.

Official sources

Statutory sources and regulators for the pharmaceutical manufacturing sector

Related guides in Health & Safety

Manufacture controlled drugs and run a safe pharmaceutical site

A task guide for pharmaceutical manufacturers (SIC division 21) on the additional licence for controlled drugs and the duties that make a pharma site safe to run. It covers the Home Office controlled-drug licence, the environmental permit for large-scale chemical synthesis, and the workplace duties for hazardous substances, work equipment and general health and safety.

Chemical manufacturer: compliance checklist

A verification checklist for makers of chemicals and chemical products (SIC division 20). Use it to confirm that UK REACH registration, GB CLP classification and labelling, product authorisation, COMAH duties, environmental permits, DSEAR controls, explosives licensing and core workplace health-and-safety duties are all in place before a production run.

Which medicines manufacturing authorisation applies

A reference router for pharmaceutical manufacturers (SIC division 21). Use it to work out which authorisation regime applies to what you make: active-substance registration for active pharmaceutical ingredients, a manufacturer's / importer's authorisation with a Qualified Person and GMP for finished medicines, and an additional Home Office licence if you make or handle controlled drugs.