General Recipe

Per ISA-88.01 §5.4.1, a General Recipe is "an enterprise level recipe that serves as a basis for lower-level recipes". It is the recipe at maximum abstraction: it knows about the product, the chemistry/biology, the process design, and the quality attributes — but nothing about which site will make it, which line, which equipment, which lot of raw material.

• Product identity, target dosage form, intended market(s).
• Critical Quality Attributes (CQAs) — assay, dissolution, impurity profile, particle size.
• Critical Process Parameters (CPPs) — temperature, time, agitation, ratios.
• Design space (ICH Q8) — the multi-dimensional combination of inputs that delivers the CQAs.
• Reference process flow — unit operations in sequence, without binding to physical units.
• Reference IPCs — what to measure, when to measure, acceptable ranges (methods abstract).
• Knowledge package — development reports, DoE results, scale-up rationale.

The General Recipe is the deliverable from R&D and process development to manufacturing. It crystallises everything learned during:

• Formulation development — components, ratios, function of each excipient.
• Process development — DoE on temperature, time, mixing, drying.
• Scale-up studies — pilot batches that confirm the design space.
• Analytical method development — assay, impurities, dissolution methods.
• Stability studies — shelf life, storage conditions, packaging requirements.

ICH Q10 §3.2.3 calls this knowledge management — the General Recipe is the auditable artefact that carries that knowledge forward into commercial manufacturing.

• Not a BMR — it has no batch identity.
• Not an MMR — it is not the master record any single site executes against; the Master Recipe is.
• Not equipment-bound — "jacketed reactor" is allowed, "R-201 at the Lyon plant" is not.
• Not market-specific — labelling, language, market-specific specs live in the Site Recipe.
• Not a SOP — SOPs describe how operators do work; the General Recipe describes what work is to be done.
• Not a CMC dossier — but it informs the dossier and shares much of its content.

Neither FDA nor EMA cite "General Recipe" by name in regulation. They reference:

• ICH Q8(R2) — pharmaceutical development, design space, QbD.
• ICH Q10 — pharmaceutical quality system, knowledge management.
• ICH Q11 — drug substance development and manufacture.
• 21 CFR 314.50(d) — CMC content in NDA submissions.
• EMA Module 3.2.P.3 — manufacture of drug product (CMC).

In practice the General Recipe is the manufacturer's internal mirror of the CMC dossier — same content, structured for operational use rather than regulatory filing.

• Draft — R&D / process development authors against the development package.
• Technical review — tech-transfer team, manufacturing science, QA scientific review.
• Approved — released for use as parent of Site Recipes; locked from edit.
• Revised — typically rare; tied to formulation changes, design-space expansion, post-approval changes (ICH Q12).
• Obsolete — product discontinued globally.

A General Recipe revision is a big event — it cascades through every Site Recipe and Master Recipe descended from it, each of which must be impact-assessed and potentially revised + re-validated. ICH Q12 lifecycle management tools (PACMP, Established Conditions) govern the regulatory commitments.

• No General Recipe layer — product knowledge fragments across every site's Master Recipe; tech transfer reinvents the wheel.
• General Recipe drifts from the CMC dossier — internal record and regulatory record diverge.
• Site-specific decisions (local supplier, market labelling) embedded — collapses the abstraction.
• Design space documented qualitatively ("around 60 °C") rather than quantitatively ("55–65 °C, 1.5–2.5 h") — control strategy unprovable.
• Knowledge package linked but not preserved — development reports lost when SharePoint migrates.
• General Recipe revised without notifying descendant Site Recipes — regulatory commitments breached unawares.
• No version of record for the General Recipe at the time of NDA filing — change reconstruction impossible.