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Pharmaceutical Quality Management by Adnan Sarwar Chaudhary

Adnan's Pharmaceutical Quality Management by Adnan Sarwar Chaudhary 3rd Edition

The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraints, demands for efficiency, and development of international regulation, supply chain complexity, and product/process complexity. In this fast-changing environment, the people and companies that learn to adapt will prosper to manufacture & deliver consistently zero-defect products to the patients.

The quality, efficacy and safety attributes of products must be ensured so that the consumer health is not compromised.

In the drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “quality policy” i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:

An appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources;

Systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed quality assurance. 

Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier. The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.

Quality Control

Quality control is a process employed to ensure a certain level of quality in a product or service.

It can be defined as: “A system for ensuring the maintenance of proper standards in manufactured. Goods, especially by periodic random inspection of the product”.

or

“Quality control refers to a procedure or a set of steps taken during the manufacturing of a product or service to ensure that it meets requirements and that the product/service is reproducible”.

Quality Assurance

Quality assurance is a wide ranging concept that covers all matters that individually or collectively influence the quality of a drug. It starts from purchase to post market surveillance.

Quality management system is one of the key for maintaining of quality in any Pharmaceutical company. After R&D large number of people works in the QC & QA department. A chemist/Pharmacist executing a qualitative analysis seeks to identify the substances in the sample. A quantitative analysis is an attempt to determine the quantity or concentration of a specific substance in the sample.

Quality Management System

Quality management is defined as the aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management.

Quality Assurance System

Formal Structures or techniques to make sure products and services consistently meet the standard required by the customer; quality systems may be validated either within your organization, or by external auditors or by both.

Good Manufacturing Practices

Good manufacturing practices are the sets of the principles, regulations, codes (law or official standard), guidelines and procedures and part of quality assurance system which must be followed by the manufacturers to ensure that the products that are consistently produce are of quality standard and appropriate for their intended use and cover the manufacturing and testing of pharmaceutical dosage form and active pharmaceutical ingredients, diagnostics, foods, various other pharmaceutical products and medical devices

Current Good Manufacturing Practices

The cGMP regulations establish requirements for all aspects of pharmaceutical manufacture. They apply to domestic and to foreign suppliers and manufacturers whose bulk components and finished pharmaceutical products are imported, distributed, or sold in this country. To ensure compliance, the FDA inspects the facilities and production records of all firms covered by these regulations.

The Code of Federal Regulations (CFR) contains The Code of Federal Regulations (CFR) contains (a) requirements for the “Current Good Pharmaceuticals” and (b) additional cGMP requirements for biologic products, (c) medicated articles, and (d) medical devices. Currency and compliance with cGMP regulations are supported through notices in the Federal Register and through the FDA’s Compliance Policy Guide and various other guidance’s issued by the FDA.

Current Good Manufacturing Practice for Finished Pharmaceuticals

General Provisions: Scope and definitions

The regulations in 21 CFR, part 211, contain the minimum GMP requirements for the preparation of finished pharmaceutical products for administration to humans or animals. Common terms used in these regulations are defined as follows: 

Active ingredient or active pharmaceutical ingredient (API): Any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals

Batch: A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture

Batch wise control: The use of validated in process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned Certification: Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable Compliance: Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices

Component: Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product

Drug product: A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo.

Inactive ingredient: Any component other than the active ingredients in a drug product

Lot: A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number

Lot number, control number, or batch number: Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined

Master record: Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product

Quality assurance: Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately

Quality audit: A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality

Quality control: The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference

Quality control unit: An organizational element designated by a firm to be responsible for the duties relating to quality control

Quarantine: An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use Representative sample: A sample that accurately portrays the whole

Reprocessing: The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process Strength: The concentration of the drug substance per unit dose or volume

Verified: Signed by a second individual or recorded by automated equipment

Validation: Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do

Process validation: Documented evidence that a process (e.g., sterilization) does what it purports to do

Validation protocol: A prospective experimental plan to produce documented evidence that the system has been validated.



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Dr. Adnan Sarwar Chaudhary 

Pharm-D (RPh) 

Quality Assurance Inspector  

Novamed Pharmaceuticals Lahore, Pakistan

Contact Detail 

Adnan.Sarwar@Novamed.com.pk 

AdnanSarwar@Pharmacist.com.pk 

+923107272436