GMP & GDP

Controls that restrict system access based on roles and responsibilities, supporting data integrity and compliance (e.g., least privilege).

A data integrity framework: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.

A periodic review of product quality data (deviations, complaints, stability, changes) to confirm process consistency and identify improvement opportunities.

Manufacturing operations designed to prevent microbial contamination in sterile products by controlling the environment, personnel practices, and sterilization of components.

A secure, computer-generated, time-stamped record that allows reconstruction of events relating to creation, modification, or deletion of electronic records.

The quality decision to release, reject, or rework a batch based on review of manufacturing/testing data, deviations, and investigations.

A controlled record documenting manufacturing and testing of a batch, including critical steps, results, deviations, and release decisions.

The process of assessing a batch against release criteria and authorising it for distribution. In the EU, QP certification is required for release.

The number of viable microorganisms on a product, component, or in a manufacturing environment prior to sterilization.

Comparison and adjustment of measuring instruments to known standards to ensure accurate readings and reliable test/process data.

A systematic approach to investigate issues, correct them, and prevent recurrence through root cause analysis, corrective actions, and preventive controls.

A formal system to propose, evaluate, approve, implement, and document changes, including assessment of impact on quality, validation, and regulatory filings.

Documented evidence that cleaning procedures consistently remove residues and contaminants to acceptable levels, preventing cross-contamination.

Definition of cleanroom grades/classes based on particulate and microbiological limits to support sterile manufacturing controls.

A temperature-controlled supply chain required to maintain product quality for temperature-sensitive materials and finished products during storage and transport.

Any communication alleging deficiencies related to identity, quality, durability, reliability, safety, or performance of a product after it is released.

Documented assurance that a computerized system consistently performs as intended in its validated state, supporting data integrity and compliance.

Ongoing assurance during routine production that the process remains in a state of control through continuous monitoring and trending of process data.

The framework of roles, policies, and controls that ensures data integrity and appropriate management of data across its lifecycle.

The completeness, consistency, and accuracy of data throughout its lifecycle, ensuring records are trustworthy and reliable for quality and regulatory decisions.

A departure from an approved instruction, procedure, specification, or expected result that requires evaluation, investigation (as appropriate), and documented disposition.

A system ensuring controlled creation, approval, distribution, versioning, and archival of GMP/GCP documents and records.

A post-implementation evaluation to confirm a CAPA prevented recurrence and improved performance as intended.

Monitoring of cleanroom environments (microbiological and particulate) to ensure aseptic/controlled areas remain within defined limits.

A test verifying sterilizing-grade filters perform as intended (e.g., bubble point) before and/or after use to support sterility assurance.

A root cause analysis tool that categorizes potential causes (e.g., methods, materials, people, equipment) to support structured investigations.

A root cause analysis technique that repeatedly asks “why” to drill down from an observed problem to an underlying cause.

Standards for the distribution of medicinal products to ensure quality and integrity are maintained through the supply chain, including storage and transport.

Quality system and manufacturing standards that ensure products are consistently produced and controlled to the quality required for their intended use. Enforced by regulatory authorities.

Principles for creating and maintaining accurate, legible, traceable records (e.g., contemporaneous entries, corrections with reason, controlled documents).

Installation Qualification, Operational Qualification, and Performance Qualification—common qualification stages used to demonstrate equipment/system suitability.

A check performed to ensure prior materials, documents, and labels are removed before starting a new operation to prevent mix-ups and contamination.

A license/authorization permitting manufacture and/or importation of medicinal products, subject to GMP compliance and oversight.

The approved master set of instructions for manufacturing a batch, from which executed batch records are produced.

An aseptic process simulation using growth media to demonstrate that aseptic manufacturing processes can produce sterile product under routine conditions.

A test result that falls outside established acceptance criteria in specifications or official compendial requirements, requiring investigation and documented disposition.

A result that is within specification but shows an unexpected trend or shift compared with historical data, often requiring evaluation to detect emerging issues.

US regulations establishing criteria for acceptance of electronic records and electronic signatures as trustworthy and equivalent to paper records and handwritten signatures.

The stage of process validation that confirms the manufacturing process as designed can perform effectively and reproducibly in the commercial setting.

Documented evidence that a process, operated within established parameters, can perform effectively and reproducibly to produce a product meeting predetermined specifications and quality attributes.

Documented verification that facilities, systems, and equipment are suitable for intended use (often including IQ/OQ/PQ as applicable).

In the EU, a person legally responsible for certifying that each batch of product has been manufactured and tested in compliance with GMP and the MA. Must meet defined education and training requirements.

A written agreement defining GMP responsibilities and quality roles between a contract giver and contract acceptor (e.g., sponsor and CMO/CRO).

The function ensuring quality systems are defined, implemented, and maintained, including oversight of GMP compliance and product release decisions.

The function performing sampling and testing of materials and product against specifications, and supporting investigations for atypical results.

The organizational structure, processes, and resources needed to implement quality policies and ensure consistent product quality and compliance.

Physical or electronic segregation status indicating that materials or product are not yet released for use or distribution pending testing, review, or investigation.

Removal or correction of a marketed product that violates regulations or poses a risk to health, performed under defined procedures and regulatory communication.

A representative sample kept for a defined period to support investigation, stability follow-up, and regulatory expectations (as applicable).

A structured approach to identify underlying causes of a problem to ensure corrective and preventive actions address true drivers rather than symptoms.

Separation of materials, intermediates, or product to prevent mix-ups and cross-contamination, including status-based controls (released/quarantine/rejected).

Unique identification of saleable units/packs to improve traceability and anti-counterfeiting controls in the supply chain (region-specific rules).

Qualification/validation demonstrating shipping configurations and controls maintain product quality under expected transport conditions.

A document describing a manufacturing site’s quality system, operations, and GMP compliance framework used in inspections and regulatory oversight.

A controlled document describing how to perform a routine operation consistently and compliantly.

A set of controls ensuring sterile products meet sterility requirements, including validated sterilization, aseptic controls, and monitoring.

A sterilization method using validated filters (commonly 0.22 μm) to remove microorganisms from solutions where terminal sterilization is not feasible.

Assessment and approval of suppliers based on capability, quality systems, and risk to ensure consistent provision of suitable materials/services.

A deviation from labeled or qualified temperature conditions during storage or transport that requires evaluation of product impact and disposition.

A study to characterize temperature distribution within a storage area (e.g., warehouse, cold room) to support qualified storage conditions.

A mapping of required training by role and task to ensure personnel are qualified to perform regulated activities.

Analysis of data over time to detect shifts, emerging risks, or deteriorating performance (e.g., EM trends, complaint trends, stability trends).

A high-level document describing an organization’s validation strategy, scope, responsibilities, and lifecycle approach across systems and processes.