PHARMACY (MEDICINE )

GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS Good manufacturing practices (GMPs) are a component of quality assurance that assures products are continuously produced and controlled to the quality standards relevant to their intended use and as required by the marketing authorization.   GMP's main goal is to reduce the risks that come with producing any kind of pharmaceutical. These   risks are of Two types  : (          (1)   cross-contamination (especially with unanticipated pollutants) and            (2)     mix-ups (confusion) brought on, for instance, by the application of misleading labels on containers.  Under GMP: - All manufacturing procedures are thoroughly defined, evaluated in light of experience, and demonstrated to be capable of producing pharmaceutical products consistently that are of the appropriate quality and conform to their specifications.   -Qualification and validation are carried out.   -Essential resources are offered, including:

  QUALITY ASSURANCE Principle :   A broad concept called "Q uality Assurance" encompasses all elements that can have an individual or overall impact on a product's quality. The sum of all the measures made to guarantee that pharmaceutical products are of the quality needed for their intended purpose. Quality  assurance consequently takes into account GMP as well as other elements, such as product development and design, that fall outside the purview of following guide. The system of quality assurance appropriate to the manufacture of pharma [1] ceutical products should ensure that: ·        -  Taking into consideration GMP's requirements as well as those of other related codes, such as good laboratory practice (GLP) and good clinical practice (GCP). ·        -  Written specifications for production and control operations and the adoption of GMP standards. ·        -  Job descriptions for managers clearly define managerial responsibilities. ·        

   QUALITY MANAGEMENT IN THE DRUG INDUSTRY Quality management is typically referred to in the larger pharmaceutical industry as the part of the management function that chooses and puts into practice the "quality policy," or the overall intention and course of an organization about quality, as formally expressed and authorized by top management. The fundamental components of quality management are: 1— an appropriate infrastructure, or "quality system ," encompassing organizational structure, procedures, processes, and resources; 2— systematic actions required to ensure sufficient confidence that a Product ( or service) will meet predetermined standards for quality. Quality assurance refers to the sum of these efforts. The management tool of quality assurance is used within a company. Quality control also helps to build supplier confidence in contractual contexts. Aspects of quality management that are interrelated include the ideas of quality assurance, G

03-   IN-PROCESS CHECKS OF TABLET   COMPRESSION ·        Check the status of the Q.C.'s released label and Report of Bulk in the batch production record file. ·        Check that the ingredients, containers, labels, and documents from preceding batches have been taken out. ·        Check the cleanliness of the ceiling, floor, doors, windows, and other surfaces. ·        Check the dust collector is turned on and operating correctly. ·        Check the HVAC system's functionality. ·        Check that the analytical balance, compression machine, and other tools are correctly cleaned and calibrated. ·        Check that everyone using protective gear is carrying it out correctly. ·        Check the physical characteristics, color, dimension, weight, thickness, hardness,  disintegration time, etc are in compliance with the product's specifications at the beginning of the compression run. ·        Check that the process is being followed by the   SOP. ·        Ch

Active pharmaceutical ingredient (API): DEF: Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.   An Illustration :                       substance or mixture of substances                                                 ↓        manufacture of a pharmaceutical dosage form                                                                      ↓                       becomes an active ingredient                                                  ↓                              pharmacological activity                                                  ↓               diagnosis, cure, mitigation, treatment, or