The following terms and definitions are provided to assist the reader in using this guidance Documentation.
Batch Number : A distinctive combination of numbers or letters from which the complete history of the manufacture, processing, packaging, coding and distribution of a batch can be determined.
Documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch or lot which include Dispensing of raw material, Granulation, Blending Compression, Capsule Filling, Coating, Inspection and yield at different stages. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.
Batch Packaging Record : Documentation that provides the history of a batch from packaging material dispensing, Blister packing, Bottle packing, Jar packing, Dry syrup Filling, labeling, Carton packing and shipper packing up to Dispatch of a Batch or Lot. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.
Active Ingredient :A substance or a bulk pharmaceutical chemical that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of the disease or to effect the structure or any function of the body of man or other animals.
Actual Yield : The quantity that is actually produced at any appropriate phase of processing of a particular product.
Theoretical Yield :The quantity that would be produced at any appropriate those of manufacture, processing or packaging of a particular drug product based upon the quantity of components to be used in the absence of any loss or error in actual production.
Acceptance Criteria :The specifications and acceptance/rejection, such as acceptable quality level and unacceptable quality levels, with an associated sampling plan that are necessary for making a decision to accept or reject the material. This term can also be applied to validation.
Analytical Methods Validation : The Process by which it is established by laboratory Studies, that the performance characteristics of the method meet the requirements for the intended Analytical Applications.
Calibration :The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements.
Certificate of analysis : A document relating specifically to the results of testing a representative sample drawn from the material to be delivered.
Cross-Contamination : A contamination of material or product with another material or product.
Expiry/Expiration Date : The date usually placed on the containers /labels of material designating the time during which the material is expected to remain within the established self life specifications if stored under defined conditions and after which it should not be used.
Finished Product : Any pharmaceutical product that has undergone all stages of production, including packaging and labeling.
In-process control :Checks perform during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.
Medicines :A manufactured, sold placed for sale or recommended substance or mixture for Treatment, relief, prevention or diagnosis of a disease, abnormal a physical state or the symptoms of one or another one in man or animals or the reestablishment, correction or the organic functions modification in man or animals.
Qualification :The action of proving that any equipment or process work correctly and consistently and produces the expected result. Qualification is part of, but not limited to a validation process, i.e. Installation Qualification (IQ), Operation Qualification(OQ) and Performance Qualification (PQ).
Operational Qualification : Operational qualification consists of verification and documentation, of the parameters of the subjected equipment.
Performance Qualification : Performance Qualification is designed to prove the process, can consistently produce a product that meets the stated requirements and specifications.
Quality Assurance :The sum total of the organized activities performed with the intent to ensure that all the activities are of the quality required for their intended use.
Quality Control : All activities such as measuring, examining, testing, or gauging one or more Characteristics of a product (including raw materials) and comparing the findings with specified requirements to determine conformity.
Production :All operations involved in the preparation of a pharmaceutical product, from receipt of raw materials through the completion of a finished product.
Validation : Documented program or evidence, that provides a high degree of assurance that a specific process method or system consistently produce a result indicating predetermined accepted criteria.
Validation Protocol :A written plan starting how validation will be conducted and identifying specific acceptance criteria. For example the protocol for a typical manufacturing process identifies processing equipments, critical process parameters/ operating ranges, Critical Quality attributes and product characteristics. Sampling and test data to be collected, number of validation runs and acceptable test results.
Prospective Validation :Establishing documented evidence that a system dos what it suppose to do prior to the commercial distribution of the new product or an existing product made by a new or modified process.
Quarantine : The status of starting or packaging materials, intermediates, Bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal.
Raw material :Any substance used in the manufacture of pharmaceutical drugs excluding Packing material.
Reconciliation : A comparison between the amount of product or material theoretically vs actually produced or used.
Retest Period : The period of time during which the material can be considered to remain within specifications and therefore acceptable for use in the manufacturer of a given drug product provided that it has been started under defined conditions.
Retrospective Validation :Establishing documented evidence that a system does what it purports to do based on a review and analysis of historic information. It is normally conducted on the drug material already being commercially distributed and is based on accumulated production, testing and control data.
Working Standard :A substance of established quality and purity as shown by comparison to a primary reference standard/used as a reference for routine lab analysis.
Standard operating procedure (SOP) :A written authorized procedure that gives a set of instructions for performing the operations.
Reprocessing : The reworking of all or part of a batch of product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations.
Product Lifecycle : Stage through which a product moves from its inception till its discontinuation. It includes pharmaceutical development, technology transfer and commercial production up to product discontinuation.