01Document control
- ✓Unique document number, title, version, effective date and scheduled review date
- ✓Author, technical reviewer and authorized pharmacy approver
- ✓Revision history that identifies what changed and why
- ✓Archived superseded versions protected from unintended use
Formula and calculations
- ✓Complete ingredient names, exact chemical forms, grades and standard batch size
- ✓Qualitative and quantitative formula with units and concentration basis clearly stated
- ✓Calculations, potency or moisture adjustments, overage rationale and independent verification
- ✓Ingredient specifications and links to supplier, lot, expiry, CoA and SDS controls
Preparation and controls
- ✓Required facility, equipment, containment, PPE and pre-use checks
- ✓Original, stepwise preparation instructions written for the pharmacy's actual process
- ✓In-process checks, theoretical yield, final yield tolerance and finished-product specifications
- ✓Packaging, container-closure system, storage, labelling and counselling requirements
Evidence and approval
- ✓Formula-specific compatibility, stability and beyond-use-date rationale
- ✓References recorded with title, publisher, edition or version, page or section and access date
- ✓Link to the formula risk assessment and applicable pharmacy SOPs
- ✓Final technical review and pharmacy authorization before implementation