Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
The PIC/S guide for preparing medicinal products in healthcare establishments — hospital pharmacies and similar settings — version PE 010-4, in force since 1 March 2014. It adapts GMP thinking to preparation at the point of care: a quality system proportionate to risk, premises and equipment, documentation, production of sterile and non-sterile preparations, and annexes for specific practices, including Annex 3 on radiopharmaceuticals. It is the international layer of the compounding cluster, distinct from the PIC/S PE 009 GMP Guide that governs industrial manufacture.
What this does not cover
stated in the document's own scope- Covers preparation in healthcare establishments; industrial manufacture under a manufacturing authorisation follows PE 009 and national GMP.
- A PIC/S guidance text: whether and when preparation is lawful without a manufacturing authorisation is a question of national medicines law, which the guide does not decide.
- International guidance: in the US the operative compounding standards are the USP chapters and federal/state compounding law, not PE 010.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
PIC/S PE 010 — the Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments — adapts GMP thinking to the setting industrial GMP was never written for: hospital pharmacies and similar establishments preparing medicines for identified patients. Version PE 010-4 has been in force since 1 March 2014. The guide scales quality expectations to risk: a pharmaceutical quality system proportionate to the scale of preparation, a risk-based decision on when preparing is justified at all versus sourcing a licensed product, premises, equipment, and documentation requirements, controls for sterile preparation, and annexes for specific practices — Annex 3 covering the preparation of radiopharmaceuticals. It is the international layer of the compounding cluster, deliberately distinct from PE 009, the PIC/S GMP guide for industrial manufacture.
Scope & applicability
Preparation of medicinal products in healthcare establishments in jurisdictions whose authorities adopt or reference PIC/S guidance — typically where a product is prepared for a specific patient or small-scale need outside an industrial manufacturing authorisation.
Legal basis & how it acquires force
A PIC/S guidance document, adopted by the Pharmaceutical Inspection Co-operation Scheme for use by its participating authorities. It binds the way PIC/S texts do: through national adoption and inspectorate practice — authorities reference it when inspecting hospital preparation, and several jurisdictions incorporate it into national rules for pharmacy preparation. It does not replace national medicines law, which determines when preparation is lawful without a manufacturing authorisation.
Document structure
| Part | Covers |
|---|---|
| Quality system and personnel | A pharmaceutical quality system proportionate to preparation risk, and responsibilities of the pharmacist and staff |
| Risk assessment and the decision to prepare | When preparation in the establishment is justified versus obtaining a licensed medicinal product |
| Premises, equipment and documentation | Facility and equipment expectations and the records giving traceability from materials to patient |
| Production and sterile preparation | Controls for non-sterile and sterile preparation, including environment and process |
| Annexes | Specific practices, including Annex 3 on the preparation of radiopharmaceuticals |
Key requirements
- A pharmaceutical quality system proportionate to the scale and risk of preparation
- Risk-based decisions on when preparation is justified versus sourcing a licensed product
- Controls for sterile preparation, including environment, process, and personnel
- Documentation providing traceability from starting materials to the administered preparation
- Application of the annexes to specific practices, including radiopharmaceutical preparation (Annex 3)
Implementation tips
- Use PE 010 as the benchmark where national compounding rules are thin — inspectorates in PIC/S jurisdictions read hospital-preparation practice against it, and its risk-based scaling maps cleanly onto USP <795>/<797> structures
Revision notes
Version PE 010-4 has been in force since 1 March 2014. PE 009 remains the separate PIC/S guide for industrial GMP.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
PE 010 occupies the space between industrial GMP and pharmacy practice: PE 009 (the PIC/S GMP Guide) governs manufacture under an authorisation, while PE 010 governs preparation in healthcare establishments, scaled by risk. Its US counterparts are the USP compounding chapters — <795>, <797>, <800>, and <825> for radiopharmaceuticals, the ground its Annex 3 covers internationally — and its risk-proportionate structure maps onto them cleanly enough that global hospital networks align both.
PIC/S PE 010-4: frequently asked questions
Quick answers to common questions about PIC/S PE 010-4.
What is the difference between PIC/S PE 009 and PE 010?
PE 009 is the PIC/S GMP Guide for industrial manufacture under a manufacturing authorisation; PE 010 adapts good practice to the preparation of medicinal products in healthcare establishments — hospital pharmacies preparing for identified patients — with requirements scaled to the risk and scale of the activity.
When did PE 010-4 come into force?
On 1 March 2014 — version 4 is the current text of the guide.
Does PE 010 cover radiopharmaceuticals?
Yes. Annex 3 addresses the preparation of radiopharmaceuticals in healthcare establishments — the same ground USP <825> covers for US practice — reflecting the short half-lives and radiation-protection constraints that make radiopharmacy its own discipline.
Is PE 010 legally binding?
Not of itself. Like other PIC/S texts it acquires force through the participating authorities: inspectorates use it as their benchmark for hospital-preparation inspections, and some jurisdictions adopt it into national requirements for pharmacy preparation.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.