GMP Glossary
A comprehensive dictionary of pharmaceutical Good Manufacturing Practice terminology, acronyms, and operational definitions as used in Revised Schedule M.
A
Ancillary Area
Supporting areas in a manufacturing facility that are not directly involved in production but support it — such as rest rooms, maintenance workshops, and animal houses.
API
Active Pharmaceutical Ingredient — Any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient.
Aseptic Processing
Manufacturing technique for sterile products where the product and container are separately sterilized and then combined in an ultra-clean environment (Grade A).
Authorized Person
The person recognized by regulatory authority as having the responsibility for ensuring that each batch of product has been manufactured and checked in compliance with laws and specifications.
B
Batch
A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous.
BMR
Batch Manufacturing Record — A document containing a complete record of the manufacturing of a specific batch of product, including all raw materials used, processing steps, and in-process test results.
BPR
Batch Packaging Record — A document containing all information related to the packaging of a specific batch, including packaging materials used, labelling details, and packaging yield calculations.
C
Calibration
A set of operations that establish the relationship between values indicated by a measuring instrument and the corresponding known values of a reference standard.
CAPA
Corrective and Preventive Action — A systematic approach to investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. Part of the quality management system.
CDSCO
Central Drugs Standard Control Organisation — India's national regulatory body for cosmetics, pharmaceuticals, and medical devices under the Ministry of Health and Family Welfare.
Change Control
A formal system to evaluate, approve, and document changes to validated systems, processes, equipment, or materials that may affect product quality.
Clean Room
A room designed and maintained to control particulate and microbial contamination. Classified from Grade A (highest cleanliness) to Grade D (lowest) based on particle count limits.
Cleaning Validation
Documented proof that an approved cleaning procedure will consistently remove product residues, cleaning agents, and microbial contamination to predetermined acceptable levels.
Containment
The practice of confining a chemical agent, biological agent, or radiological agent within a defined space to prevent its release into the surrounding environment.
Cross-Contamination
Contamination of a material or product with another material or product. Must be prevented through proper design, procedures, and cleaning validation.
D
Deviation
A departure from an approved procedure or established standard. All deviations must be documented, investigated, and addressed through the CAPA system.
E
Environmental Monitoring
Systematic monitoring of air quality, surface contamination, temperature, humidity, and differential pressure in manufacturing areas to ensure compliance with defined limits.
F
FPP
Finished Pharmaceutical Product — A finished dosage form of a pharmaceutical product which has undergone all stages of manufacture, including packaging in its final container.
G
GMP
Good Manufacturing Practice — A system ensuring products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from starting materials, premises and equipment to the training and personal hygiene of staff.
Grade A
The highest cleanliness classification for clean rooms. Used for high-risk operations such as filling, making aseptic connections, and stopper bowls. Particle limit: 3,520 particles ≥0.5μm per m³ at rest.
Grade B
Clean room classification serving as the immediate background environment for Grade A zones. Used for aseptic preparation and filling. Particle limit: 3,520 particles ≥0.5μm per m³ at rest.
Grade C
Clean room classification used for less critical stages of sterile product manufacturing. Particle limit: 352,000 particles ≥0.5μm per m³ at rest.
Grade D
The minimum clean room classification for manufacturing environments. Used for less critical manufacturing steps. Particle limit: 3,520,000 particles ≥0.5μm per m³ at rest.
H
HEPA Filter
High-Efficiency Particulate Air filter — A filter that removes at least 99.97% of particles at 0.3 microns. Required in sterile manufacturing areas with integrity testing every six months.
HVAC
Heating, Ventilation, and Air Conditioning — Systems that control temperature, humidity, air pressure, and particulate levels in manufacturing areas. Critical for maintaining cleanroom classifications.
I
In-Process Control
Checks performed during production to monitor and, if necessary, adjust the process to ensure the product conforms to specifications. Includes pH, weight, hardness testing etc.
IQ
Installation Qualification — Documented verification that the equipment or system is installed according to the manufacturer's specifications and design requirements.
L
Lot
A batch or a specific identified portion of a batch, having uniform character and quality within specified limits. Sometimes used interchangeably with 'Batch'.
M
Master Formula
An authorized document that specifies the starting materials with their quantities and the packaging materials, together with a detailed description of the procedure and precautions for manufacturing.
O
OOS
Out-of-Specification — A test result that falls outside the established acceptance criteria. Requires formal investigation and must be completed within 30 days.
OQ
Operational Qualification — Documented verification that the equipment or system operates as intended throughout all anticipated operating ranges.
P
Pharmacopoeia
An official publication containing standards and quality specifications for medicines, directions for sampling, and methods of examination. Indian Pharmacopoeia (IP) is the national standard.
PQ
Performance Qualification — Documented verification that the equipment or system performs consistently and reproducibly during routine use with actual products.
Product Recall
A process of withdrawing or removing a pharmaceutical product from the market due to quality defects or safety concerns. Must be documented with root cause analysis.
Q
QA
Quality Assurance — The sum total of organized arrangements to ensure products are of the quality required for their intended use. QA encompasses GMP and other factors like product design and development.
QC
Quality Control — Part of GMP concerned with sampling, specifications, testing, documentation and release procedures. QC ensures necessary and relevant tests are performed before materials are used or products released.
Qualification
The action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and lead to expected results. Includes IQ, OQ, and PQ.
Quarantine
The status of materials or products isolated physically or by other effective means while a decision on their approval or rejection is awaited.
R
Reprocessing
Repeating one or more steps of a manufacturing process for a batch that does not meet specifications. Must be authorized by QA and documented.
S
Self-Inspection
A systematic evaluation of the company's own procedures, records, and systems to verify compliance with GMP requirements. Must be conducted at least every six months.
Shelf Life
The time period during which a pharmaceutical product is expected to remain within approved specifications when stored under defined conditions.
SOP
Standard Operating Procedure — A written document giving detailed instructions for performing a specific operation. SOPs ensure consistent performance and must be reviewed at least every two years.
Stability
The ability of a pharmaceutical product to maintain its physical, chemical, microbiological, and biopharmaceutical specifications throughout its shelf life.
V
Validation
The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results under defined conditions.
W
Water for Injection (WFI)
The highest purity water grade used in pharmaceutical manufacturing. Produced by distillation or reverse osmosis and used for parenteral products.
Y
Yield
The quantity of product obtained at any stage of manufacture compared to the theoretical expected quantity. Significant yield variations require investigation.