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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.
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