Important abbreviations need to know every pharmacy students

ABBREVIATIONS FREQUENTLY USED IN PHARMACEUTICALS

N.B: Probably Most used terms may green color 

AHU: Air Handling Unit 

AQL: Acceptable Quality Level

API: Active Pharmaceutical Ingredients

GLP: Good Laboratories Practice

ICH: International Conference on Harmonization

ISO: International Standard Organization/ International Organization for Standardization

GMP: Good Manufacturing Practice

cGMP: Current Good Manufacturing Practice

TQM: Total Quality Management

WHO:  World Health Organization

WHA: World Health Assembly

BMR: Batch Manufacturing Records

BPR: Batch Packaging Records

FDA: Food and Drug Administration

FD & C: Food, Drug and Cosmetics

IPC: In-Process Control/ Check

CBA: Collective Bargaining Agent

MCA: Medicines Control Agency (Britain)

MCC: Medicine Control Council (Africa)

ICRS:  International Chemical Reference Substances 

IRO: Industrial Relations Ordinance

EEC:  European Commission;

ISO/TC: International Organization for Standardization Technical Committee

PDCA: Plan, Do, Check, Act

PIC: Pharmaceutical Inspection Convention

PIC/S: Pharmaceutical Inspection Co-operation Scheme

DQ: Design Qualification

IQ: Installation Qualification

OQ: Operational Qualification

PQ: Performance Qualification

ASL: Approved Suppliers’ List

VMP: Validation Master Plan

TRS: Technical Report Series

CRS: Chemical Reference Substances

HEPA: High Efficiency Particulate Air

SAL: Sterility Assurance Level

IU: International Unit

IUPAC: International Union of Pure and Applied Chemistry

ANOVA: Analysis of Variance

HEPA: High Efficiency Particulate Air

HPLC: High Performance Liquid Chromatography

ICDRA: International Conference of Drug Regulatory Authorities

TLC: Thin Layer Chromatography

GC: Gas Chromatography

PVC: Poly Vinyl Chloride

PVDC: Poly Vinyledene Chloride

ROPP: Rolled on Pilfer Proof

RCC: Reinforced concrete

FTIR: Fourier Transform Infrared spectroscopy 

LAL: Limulus Amebocyte Lysate

RO: Reverse Osmosis

WFI: Water for Injection

FIFO: First-in-first-Out

FEFO: First Expired, First Out

EEFO: Earliest Expiry, First Out

HACCP: Hazard Analysis and Critical Control Point

FIP: International Pharmaceutical Federation

INN: International Non-proprietary Names

IFPMA: International Federation of Pharmaceutical Manufacturers Associations

IPEC: International Pharmaceutical Excipients Council

UNICEF: United Nations Children’s Fund

WTO: World Trade Organization

PDG: Pharmacopoeial Discussion Group

GTDP: Good trade and distribution practice

DAR: Drug Administration Registration           

DMF: Drug Master File                                    

DRA: Drug Regulatory Authority

EOI: Expression of Interest

ILO: International Labor Organization

NPS: Nonpareil seed

EDM: Essential Drugs and Medicines

BAN: British Approved Names

USAN: United States Accepted Names

GSP: Good storage practice

   MOA: Method of analysis

COA: Certificate of analysis

UNAIDS: United Nations Programme on HIV/AIDS

UNFPA: United Nations Population Fund

ASEAN: Association of South Asian Nations

TPN: Total Parenteral Nutrition       

BFS: Blow, Fill, Seal Technique (Ampule Filling)

LDPE: Low Density Polyethylene

HDPE: High Density Polyethylene

PP: Polypropylene

HVAC: Heat, Ventilation and Air conditioning

PPIC: Production Planning & Inventory Control

PPI: Proton Pump Inhibitor            

o. d.: Once daily

b. i. d.: Twice daily

TOC: Total Organic Carbon

t. i. d.: Thrice daily

q. i. d.: Four times daily

PMN: Phenylmercuric Nitrate

PMA: Phenylmercuric Acetate

BAC:  Benzalkonium Chloride

PVDC: Polyvinylidene Chloride

NE: Not Established

PET: Polyethylene Terephthalate

FAO: Food and Agriculture Organization

EEC: European Commission

USAID: U.S. Agency for International Development

ICDDRB: International Centre for Diarrhoeal Disease Research, Bangladesh

IBC: Intermediate Bulk Container

AAS: Atomic Absorption Spectroscopy

ICP: Inductively Coupled Spectroscopy

IC: Ion Chromatography

TGA: Therapeutic Goods Agency (Australia)

MHRA: Medicines and Healthcare products Regulatory Agency (UK)

What is a Change Request?

Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.

What's Validation Summary Report?

Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:

    A description of the validation project

   All test cases performed, including if those test cases passed without issue

   All deviations reported, including how those deviations were resolved

What's a PQ Document?

Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.

What's an OQ Document?

Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.

What's Validation Plan?

Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:

    Deliverable s (Documents) to be generated during the validation process

   Resources/Departments/Personnel to participate in the validation project

   Time-Line for completing the validation project

What are user requirements ?

User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.

21 CFR part 11

What is 21 CFR part 11 ?

The title 21 CFR Part 11 is the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records

Some Important terms..

What is an  SOP ?

SOP that means Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.