SOP for Abbreviations used in Standard Operating Procedures and other documents |
1.0 OBJECTIVE :
- To describe all the Definitions and Abbreviations used in Standard Operating Procedures, Master Formula Records and other documents.
2.0 SCOPE :
- The SOP covers list of words to be used in abbreviated form.
3.0 RESPONSIBILITY :
- Quality Assurance Chemist and above
- Q.A. Head
5.0 PROCEDURE :
- Restrict using words in abbreviated form.
- An abbreviation is a shortened form of a word or phrase. It consists of a group of letters taken from the word or phrase.
5.1 Air Lock definition:
- An enclosed space with two or more doors which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the air flow between those rooms when they need to be entered. An airlock is designed for and used by either people or goods.
5.2 Authorized person definition:
- A person responsible for the Approval of batches of finished product for sale/ supply/ dispatch.
5.3 Batch definition:
- A defined quantity of starting material, packaging material or product processed in a single process or series of processes so that it could be expected to be homogeneous.
5.4 Lot definition:
- It may sometimes be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogenous batch.
5.5 Batch No (or Lot No.) definition:
- A distinctive combinations of numbers and / or letters which specifically identifies the batch / Lot on the labels, the batch records, the certificates of analysis, etc.
5.6 Batch Records definition:
- All records associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.
5.7 Bulk product definition:
- Any product that has completed all processing stages, but not including, final packaging.
5.8 Calibration definition:
- The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
5.9 Clean area definition:
- An area with defined environmental control of particulate and microbial Contamination constructed and used in such a way as to reduce the introduction, generation, and retention of contamination within the area.
5.10 Consignment or Delivery definition:
- The quantity of starting material, or of a Drug product, made by one manufacturer and supplied at one time in response to a particular request or order consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
5.11 Critical process definition:
- A process that may cause variation in the quality of the Pharmaceutical product.
5.12 Cross contamination definition:
- Contamination of starting material, intermediate Product, or finished product with another starting material or product during production.
5.13 Finished product definition:
- A product that has undergone all stages of production, including packaging unit’s final container and labeling.
5.14 In process control definition:
- Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specification. The control of the environment or equipment may also be regarded as a part of in process control.
5.15 Intermediate product definition:
- Partly processed material that must undergo further Manufacturing steps before it becomes a bulk product.
5.16 Manufacturer definition:
- All operations of purchase of materials and products, production, quality control ,release, storage, shipment ,of finished product and the related control.
5.17 Master Formula definition:
- A document or set of documents specifying the starting materials with their quantities and their packaging materials, together with the description of the procedures and precautions required to produce a specified Quantity of a finished product as well as the processing instructions including the In process control.
5.18 Master Record definition:
- A document or set of document that serve as basis for the batch documentation (Blank Batch Record).
5.19 Packaging definition:
- All operations including filling and labeling, that a bulk product has to undergo in order to become a finished product.
5.20 Packaging Material definition:
- Any material, including printed material, employed in the pharmaceutical product, excluding any outer packaging used for transportation or shipment. Packaging materials are referred as a primary or secondary according to whether or not they are intended to be in direct contact with the product.
5.21 Production definition:
- All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging to Completion of finished goods.
5.22 Quarantine definition:
- The status of starting or packaging materials, intermediates, or bulk or finished product isolated physically or by other effective means while a decision is awaited on their approval , rejection or reprocessing.
5.23 Reconciliation definition:
- A comparison, making due allowance for normal variation, between the amount of product or material theoretically produced or used and the amount actually produced or used.
5.24 Reprocessing definition:
- The reworking of all or part of a batch of product of an unacceptable quality from a defined stage of production so that it`s quality may be rendered acceptable by one or more additional operations.
5.25 Specification definition:
- A document describing in detail the requirement with which the product or materials used or obtained during manufacture have to conform. Specifications serve the basis for quality evaluation.
5.26 Standard Operating Procedure ( SOP ) definition:
- An authorized written procedure giving instruction for performing operation not necessarily specific to a given product or material but of a more general nature (e.g. Equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOP`s may be used to supplement Product-specific master and batch production documentation.
5.27 System definition:
- A regulated pattern of interacting activities and techniques that are united to form an organized whole.
5.28 Validation definition:
- The documented act of providing that any procedure, process, equipment, material, activity, or system leads to the expected results.
5.29 Good Manufacturing Practice definition:
- It is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing Authorization.
5.30 Quality Control definition:
- It is the part of GMP concerned with sampling, specification and testing and with the organization, documentation, and release procedures which ensures that a necessary and relevant test are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been to be satisfactory.
5.31 Quality Assurance definition:
- Systematic action necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality.
5.32 Abbreviations definition:
Following words can be used in abbreviation form in documents both preprinted and data entered.
|In Process Quality Assurance
|Good Manufacturing Practice
|Standard Operating Procedure
|Fluidized Bed Drier
|Rapid Mixer Granulator
|Master Formula Record
|Batch Manufacturing Record
|Batch Packing Record
|In House Specification
|United States Pharmacopoeia
|Standard Testing Procedure
|Empty Hard Gelatin
|Revolutions per Minute
|Air Handling Unit
|High Efficiency Particulate Air filter
|Loss On Drying
|Left Hand Side
|Right Hand Side
|Weight / Weight
|Annual Product Quality Review
|Corrective Action Preventive Action
|Not More Than
|Not Less Than
|Process Validation Protocol
|Process Validation Report
|Colony Forming unit
|Parts Per Million
|Human Resource Department
|Ware House Department
|Pounds per square inch
|Part per million
|Relative Standard Deviation
8.0 SOP REFERENCES
- British Pharmacopeia
- United State Pharmacopeia
END OF THE SOP