MANU LAS 1

• Actual Yield


  The quality that is actually produced at any phase of production of a particular drug based on the initial input.
• Active Ingredient or Active


  Any component which is intended to furnish pharmacological activity or other effects on the diagnosis, cure, mitigation, treatment or prevention of disease, or to effect the structure or function of the body.
• Batch


  A quantity of drug product/device that is homogeneous in character and quality produced during a given cycle of manufacturing and from a specific manufacturing order.
• Batch Number


  A designation of number or letter or combination thereof that identifies the batch and permits the tracing of the complete history if batch, including all stages of its production, control and distribution.
• Batch Number


  Also known as Lot Number
• Bulk Product


  Any processed material which has to undergo another process including packaging operation to become a finished product.
• Component


  Any material intended to be used for the manufacturer of a product, whether raw materials or packaging materials.
• Cosmetics


  Articles intended to be rubbed, poured, sprinkled, or otherwise applied to the human body or any part thereof, for cleansing, beautifying, promoting attractiveness, or altering the appearance.
• Cosmetics


  Articles intended or used as a component of any such articles, except that such term shall not include soap.
• Date of manufacture


  The date indicating the start of processing of every batch.
• Dispensing


  The activity of weighing, counting, or measuring and checking of starting materials and issuing these materials to the appropriate production personnel, details of the activity being duly and properly documented.
• Drug Product


  Any substance or mixture of substances finished dosage forms that are manufactured, offered for sale or presented for use
• Device


  Instrument, apparatus or contrivances, including their components, parts and accessories intended
• Expiration Date


  A date fixed for each individual batch on or before which the batch is expected to meet the standard specifications for quality, safety and efficacy
• Finished Product


  A product which has undergone all stages of manufacturing operations
• Good Manufacturing Practices (GMP)


  It is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.
• In-Process Control


  Checks and tests instituted and carried out in the course of the manufacture of a drug to ensure identity, strength, quality and purity.
• Intermediate Product


  Any processed substance or mixture of substances which have to undergo one or more states of processing to become finished product
• Lot


  A batch or any portion of a batch produced by a continuous process, an amount of drugs produced in a unit of time, or quantity in a manner that ensures its uniformity and in either case is identified by a distinctive lot number and has a uniform character and quality within specified limits.
• Manufacture or Manufacturing


  The complete set of activities to produce a drug, comprising production and quality control from dispensing of materials to the distribution of the finished product.
• Manufacture Order (MO)


  It is an instruction to the Production or Manufacturing Department to produce a drug distribution.
• Master Formula (MF)


  The standard form where the Manufacturing Order is derived. It is prepared by the competent people of the company.
• Packaging


  The process of packing, the part of the production cycle applied to a bulk product to obtain finished product.
• Packaging Material


  Any material used in the packaging of a bulk product to obtain a finished product.
• Procedures


  Description of the operations to be executed, the precautions to be implemented directly or indirectly related to the manufacture of a drug.
• Processing


  The part of the production cycle from weighing of raw materials to finished product.
• Production


  All operations starting from dispensing materials to processing, packaging, to a finished product.
• Quality Control


  All control measures designed to ensure that finished products consistently condor, to established specification of identity, purity, strength and quality.
• Quarantine


  An act of holding off a material for use, or a product for packaging or distribution by physically setting it apart or by a system duly validated, pending a decision on release or rejection.
• Raw Material


  All substances whether active or excipients that are employed in the processing of a finished product.
• Rejected


  The status of materials or products which are not permitted to be used for processing, packaging or distribution
• Released or Passed


  The status of materials or products which are permitted to be used for processing, packaging or distribution.
• Representative Sample


  A sample representing the lot, the batch, or the total amount of materials based on a sampling plan.
• Returned Product


  Any finished product which is already in distribution and sent back to the manufacturer or distributor due to a complaint, damage, expiration, validity, or other reasons such as the condition of the container or package which may cast doubt on the product identity, quality, strength and safety.
• Starting Materials


  Raw materials used in the production.
• Theoretical Yield


  The quantity that is expected or planned to be obtained at any phase of production based on the quantity of components.