GACP, GMP & Export

This page collects the quality-system, documentation and shipping terms that appear in GACP and GMP files and in export paperwork. Each entry explains what the term means and which stage of the chain it belongs to.

batch record

The documentation covering one defined batch, assembled as the work proceeds rather than written afterwards. It typically gathers the identity of the starting material, the dates and conditions of each step, the equipment and staff involved, quantities in and out, and any analysis carried out, so the batch can be reconstructed later.

bill of lading

A transport document issued by the carrier to the shipper for a consignment. It serves as a receipt for the goods, sets out the agreed terms of carriage, and in its negotiable form is a document of title, meaning that whoever holds the original is entitled to collect the goods at destination.

certificate of origin

A document identifying the country in which the goods in a consignment were produced. It is issued by a chamber of commerce or another authorised body on the exporter's declaration, and is used by customs at the destination to determine which tariff treatment applies to the shipment.

clean room classification

A grading system for rooms in which airborne contamination is controlled, based on the concentration of particles permitted in the air. Such a room is built with a filtered air supply, controlled pressure and restricted entry, and its grade is confirmed by measurement rather than assumed from the design.

cold chain logistics

The handling and transport of goods within a controlled temperature range, unbroken from dispatch to delivery. It covers refrigerated storage, insulated or refrigerated vehicles, packaging that holds temperature during transfers, and monitoring devices that record the temperature so the record can be reviewed on arrival.

deviation / CAPA

A deviation is a recorded departure from what a procedure specified. CAPA, corrective and preventive action, is the follow-up: the correction applied to the affected material, the investigation of why it happened, and the change made so that it is less likely to recur. Both are written records rather than informal fixes.

EU-GMP

The version of Good Manufacturing Practice set out in the European Union's guidelines for medicinal products. Manufacturing sites are assessed against it by the competent authority of an EU member state. The term is also used commercially to describe material produced at a site that holds such an assessment.

Good Agricultural and Collection Practices (GACP)

A set of guidelines covering how medicinal and aromatic plants are grown, collected, handled and documented, so that the identity, cleanliness and consistency of the harvested material can be shown. GACP addresses the stages from propagation to the point where harvested material passes into processing, including record keeping, hygiene and staff training.

Good Distribution Practice (GDP)

A framework covering how goods are stored, handled and transported after manufacture, so that quality and traceability are maintained until delivery. It deals with warehousing conditions, temperature control, vehicle and shipment records, and the checks applied to suppliers and customers along the distribution chain.

Good Manufacturing Practice (GMP)

A framework for how a manufacturing operation is organised and documented so that what it produces is consistent and traceable. It covers premises, equipment, personnel, written procedures, materials management, testing and records. GMP applies to processing and manufacturing steps, whereas GACP applies to the growing and collection stages that come before them.

Harmonized System (HS) code

An international numbering system for classifying traded goods, maintained by the World Customs Organization and used by customs administrations worldwide. The first six digits are common internationally and identify the goods; individual countries add further digits of their own. The code assigned governs how a shipment is treated at the border.

International Council for Harmonisation (ICH)

A body in which regulatory authorities and the pharmaceutical industry agree common technical guidelines, so that the same studies and document formats are accepted in more than one region. Its guidelines cover quality, safety and efficacy topics, and take effect by being adopted into each participating region's own rules.

International Organization for Standardization (ISO)

An independent international body that develops and publishes voluntary standards covering management systems, test methods and technical specifications. An ISO standard is a written document; where a site is described as certified, an accredited certification body has assessed that site against a named standard.

irradiation (gamma / e-beam)

A treatment in which material is exposed to ionising radiation to reduce the number of viable micro-organisms it carries. Gamma irradiation uses a radioactive source; electron beam treatment uses an accelerator. The material is not made radioactive, and the treatment is applied to sealed packaging as a separate processing step.

phytosanitary certificate

An official document issued by the plant protection authority of the exporting country for one consignment, stating that the consignment was inspected and found to correspond to the plant health requirements of the importing country. It is issued per shipment and refers to that shipment's plant material.

qualification (IQ/OQ/PQ)

The staged checking of a piece of equipment: installation qualification records that it was installed as specified, operational qualification that it performs across its working range, and performance qualification that it delivers the intended result with the actual materials in normal use. Qualification concerns equipment; validation concerns processes and methods.

quality assurance (QA)

The part of an organisation concerned with the system itself: procedures, documentation, training, change control, audits and the release of finished batches. Quality assurance asks whether the arrangements in place are capable of producing a consistent result and whether they were actually followed, rather than testing individual samples.

quality control (QC)

The function that carries out or arranges the testing and inspection of samples and records the results. Quality control deals with the material in front of it, producing measured values and inspection findings, while quality assurance deals with the system that generated that material in the first place.

seed-to-sale tracking

An inventory system that records plant material continuously from propagation through growing, harvest, processing and dispatch, with each unit carrying an identifier that persists through every change of form and every transfer. It is the software expression of traceability, used where a regulator or a buyer wants to reconstruct the full history.

shelf life

The period, counted from a defined starting point, during which a material is expected to stay within its stated specification when it is stored as instructed. It is derived from stability data for that type of material and is tied to the storage conditions given; different conditions give a different period.

stability testing

A study of how the properties of a material change over time when it is held under defined storage conditions. Samples from the same batch are stored and analysed at intervals, and the results show which characteristics drift and how quickly. It is the evidence behind a stated shelf life and storage instruction.

standard operating procedure (SOP)

A written document setting out how one defined task is carried out at a particular site: the steps in order, who performs them, what equipment and materials are used, and what is recorded. SOPs make a routine repeatable between staff and over time, and the records they generate form part of the site's documentation.

traceability

The ability to follow a defined quantity of material in both directions through records: back to the field, seed lot and inputs it came from, and forward to where it went. It depends on every step carrying an identifier and on the records linking one identifier to the next without a gap.

validation

Documented work showing that a process, method or system consistently produces the intended result. It involves defining what the result should be, running the process under controlled conditions, measuring what happens and recording the evidence. Validation is done for a defined set of conditions and repeated when those conditions change.