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| Quality Assurance(QA) |
In the pharmaceutical industry at large, quality management is usually defined as an aspect of the management function that determines and enforces a "quality policy", that is, the overall intent and direction of the organization regarding quality, as Formally expressed and authorized by top management. The basic elements of quality management are:
- An appropriate infrastructure or "quality system", incorporating organizational structure, processes, processes, and resources;
- Systematic actions to ensure sufficient confidence that a product (or service) will meet the given requirements for quality. The totality of these functions is called "quality assurance".
Within an organization, quality assurance serves as a
management tool. In contractual situations, quality assurance also serves to
generate trust in the supplier. The concepts of quality assurance, GMP and
quality control are related aspects of quality management. They are described
here to emphasize their relationships and their fundamental importance for the
production and control of pharmaceutical products.
Quality Assurance(QA)
principle; "Quality assurance" is a broad
concept covering all matters that affect the quality of a product, individually
or collectively. It is the totality of the arrangement made with the object of
ensuring that pharmaceutical products are of the required quality for their
intended use. Quality assurance, therefore, covers GMP and other factors,
including products outside the scope of this guide such as design and
development.
Appropriate quality assurance system for the
manufacture of pharmaceutical products should ensure that:
- Pharmaceutical products are designed and developed in a way that takes into account the requirements of GMP and other associated codes such as good laboratory practice (GLP) 1 and good clinical practice (GCP);
- Production and control operations are specified in a written form and GMP requirements are adopted
- Managerial responsibilities are specified in the job description;
- Arrangements are made for the manufacture, supply and use of correct starting and packaging materials;
- All necessary controls are carried out on materials, intermediate products, and bulk products and other-process control, calibration and verification;
- The finished product is properly processed and tested according to defined procedures;
- Pharmaceutical products not sold or supplied to authorized persons have certified that each production batch is produced and controlled as per the requirements of the marketing authorization and any other regulations related to production, control of pharmaceutical products. And release;
- Satisfactory arrangements exist to ensure that, as far as possible, pharmaceutical products are manufactured, delivered, and subsequently handled by the manufacturer so that their shelf-life remains quality ;
- A process for self-inspection and / or quality audit that regularly clarifies the effectiveness and applicability of the quality assurance system;
- Deviations are reported, examined, and recorded;
- A system for approving changes that may impact on product quality;
- Regular assessment of the quality of pharmaceutical products should be done to verify the stability of the process and ensure its continuous improvement.
- Manufacturers must take responsibility for the quality of pharmaceutical products to ensure they are suitable for their intended use, comply with marketing authority requirements, and do not put patients at risk due to insufficient safety, quality, or efficacy.
- Achieving this quality objective is the responsibility of senior management and requires the involvement and commitment of employees in many different departments and at all levels within the company, the company's suppliers and distributors.
To achieve the quality objective reliably, there should
be a widely designed and properly implemented system of quality assurance
involving GMP and quality control. It should be fully documented and its
effectiveness monitored. All parts of the quality assurance system must be
adequately trained with competent personnel, and have appropriate and adequate
premises, equipment and facilities.
Good Manufacturing Practices for Pharmaceutical Product (GMP)
Good manufacturing practice is the part of quality
assurance that ensures that the production of products and control over quality
standards is done for their proper use and as required by the marketing
authorization. GMP is primarily aimed at reducing the risks inherent in any
pharmaceutical production. Such risks are essentially of two types: cross con
densities (especially due to unexpected contaminants) and mix-ups (confusion)
that are caused, for example, by false labels being placed on containers.
Under GMP:
(B) Qualification and verification is done;
(C) All necessary resources have been made available, including:
- (i) Properly qualified and trained personnel;
- (ii) adequate premises and space;
- (iii) appropriate equipment and services;
- (iv) appropriate materials, containers, and labels;
- (v) approved procedures and instructions;
- (vi) appropriate storage and transportation;
- (vii) Adequate personnel, laboratories, and equipment for the process control;
(d) Instructions and procedures are written clearly and
clearly, Language applies specifically to the facilities provided;
(E) Operators are trained to carry out the procedures
correctly;
(F) during record manufacturing (manually and/or by
recording equipment) to show that all steps required by defined procedures and
instructions are taken and that the quantity and quality of the product conform
to the expectation; Any significant deviations are fully recorded and
investigated;
(G) records covering manufacture and distribution,
which can trace the complete history of a batch, are maintained in an
accessible and accessible form;
(H) Proper storage and distribution of products
minimizes any risk to their quality;
(i) a system is available to recall any batch of
product from sale or supply;
(J) Complaints about marketed products are
investigated, reasons for quality defects are investigated, and appropriate
measures are taken about defective products to prevent a recurrence.
Cleanliness and Hygiene
- High levels of hygiene and hygiene should be practiced in every aspect of manufacturing pharmaceutical products. The scope of sanitation and hygiene includes personnel, premises, equipment and equipment, production materials and containers, products for cleaning and disinfection and anything else that may become a source of contamination of the product.
- Potential sources of contamination should be eliminated through an integrated comprehensive program of cleanliness and hygiene.
Qualification and validation
According to the GMP, each pharmaceutical company must
find out what qualification and validation work is necessary to prove that important
aspects of their particular operation are controlled.
The key elements of a company's qualification and
validation program should be clearly defined and documented in a validation
master plan.
Qualification and validation should establish and provide
documentary evidence:
(A) The premises, supporting utilities, equipment and
processes are designed by the requirements of the GMP (Design Qualification, or
DQ);
(B) The premises, auxiliary utilities, and equipment
are built and installed in compliance with their design specifications
(installability, or IQ);
(C) The premises, auxiliary facilities, and equipment
operate according to their design specifications (operational qualification, or
OQ);
(D) A specific process will consistently produce a product
meeting its predefined specifications and quality characteristics (process
validation, or PV, also known as performance qualification or PQ).
Complaints
principle; All complaints and possibly other
information related to defective products should be carefully reviewed
according to written procedures and corrective action is taken.
product recalls
principle; There should be a system of recall from the
market, immediately and effectively, known products or suspected to be
defective
Contract production and analysis
principle; Contract production and analysis must be
defined correctly,
Agreed and controlled to avoid misunderstanding that
may result in an analysis of a product or function of unsatisfactory quality.
Self Inspection and Quality Audits
principle; The purpose of self-inspection is to
evaluate the manufacturer's compliance with GMP in all aspects of production
and quality control. The self-reliance program should be designed to detect any
deficiencies in the implementation of the GMP and recommend the necessary
corrective action. Self-inspections should be done regularly, and moreover, can
be done on special occasions, e.g. In case of product or repeated rejection, or
when the inspection is announced by health authorities. The team
Self-inspection should consist of a responsible person
who can objectively evaluate the implementation of GMP. All recommendations
should be implemented for corrective action. The process for self-inspection
must be documented, and there should be an effective follow-up program.
Items for self-inspection
Self-inspection written instructions should be
established to provide minimum and uniform standards of requirements. These may
include a questionnaire on GMP requirements to include at least the following
items:
- (A) personnel;
- (B) premises including personnel facilities;
- (C) maintenance of buildings and equipment;
- (D) storage of starting materials and finished products;
- (E) equipment;
- (F) production and in-process control;
- (G) quality control;
- (H) documentation;
- (i) Cleanliness and Hygiene;
- (J) validation and invalid programs;
- (k) calibration of instruments or measurement systems;
- (L) recall processes;
- (M) complaint management;
- (N) label control;
- (O) Results of previous self-inspection and any corrective steps.
Personnel
principle; The establishment and maintenance of a
satisfactory system of quality assurance and the correct manufacture and
control of pharmaceutical products and active ingredients depending on the
people. For this reason, there must be sufficient qualified personnel to
perform all the tasks for which the manufacturer is responsible. Personal
responsibilities should be clearly defined and understood as written
descriptions by the individuals concerned.
key personnel
Key personnel includes head of the production, head of
quality control and authorized person. Generally, key positions must be
occupied by full-time personnel. The head of production and quality control
should be independent Of each other.
In large organizations, it may be necessary to delegate
some tasks; However, responsibility cannot be assigned.
Key personnel responsible for the manufacture of
pharmaceutical products and overseeing quality control must have the
qualifications for scientific education and practical experience required by
national law. Their education should include studying the appropriate
combination:
- (A) Chemistry (analytical or biological) or biochemistry;
- (b) Chemical Engineering;
- (c) microbiology;
- (D) pharmaceutical science and technology;
- (E) Pharmacology and Toxicology;
- (F) Physiology;
- (G) Other related sciences.
They should have sufficient practical experience in the
manufacturing and quality assurance of pharmaceutical products. To gain such
experience, an initial period may be required, during which they must perform
their duties under professional guidance. Experts should have a scientific
education and practical experience so that they can practice independently
Professional judgment is based on the application of
scientific principles and understanding of practical problems encountered in
the manufacture and quality control of pharmaceutical products.
Training
Manufacturers should provide training according to a
written schedule for all personnel whose duties they must provide in
manufacturing areas or for control laboratories (including technical,
maintenance and cleaning personnel) and other personnel as necessary.
In addition to basic training on the theory and
practice of GMPs, newly recruited personnel should receive training following
the duties assigned to them. Continuous training should also be given, and its
practical effects should be evaluated periodically. Approved training programs
should be available. Training records should be kept.
Personnel working in areas where there is a risk of
pollution, e.g. Clean areas or areas where highly active, toxic, infectious or
sensitizing materials are handled should be given specific training-medical
products.
personal hygiene
- All personnel appropriate before and during employment should undergo health examinations. Personnel performing visual inspection should also periodically examine the eyes.
- All personnel should be trained in the practice of personal hygiene. A high level of personal hygiene should be observed by everyone concerned with manufacturing processes. In particular, personnel should be instructed to wash their hands before entering production areas. Signs to this effect should be posted and instructions should be followed.
- Any person has at any time been shown to have an apparent disease or open sores which may adversely affect the quality of the products, the materials, packaging materials until the condition is no longer estimated. -Process materials or pharmaceutical products should not be allowed to be handled. Be a risk
- All employees should be instructed and encouraged to report to their immediate supervisor any situation (related to plant, equipment or personnel) that they believe may adversely affect the products.
- Direct contact between the operator's hands and starting materials, primary packaging material and intermediate or bulk product should be avoided.
- To ensure product safety from contamination, personnel must cover the body for the duties they perform, including appropriate hair covering. Clothes used, if reusable, should be stored in separate closed containers until well plundered and, if necessary, disinfected or sterilized.
- Smoking, eating, drinking, chewing, and keeping plants, food, drinks, smoking paraphernalia, and personal drugs should not be permitted in production, laboratory and storage areas, or any other areas where they may adversely affect the quality of life.
Equipment
Devices must be located, designed, manufactured,
customized, and tailored to the operations to be performed. Aiming to allow
effective cleaning and maintenance to reduce the risk of errors in the layout
and design of equipment and avoid cross-contamination, dust or dirt buildup,
and in general, any adverse effects on the quality of products needed
Material
- theory. The main objective of the pharmaceutical plant is to produce finished products for the use of patients by a combination of ingredients (starting and packaging).
The documentation
Principles. Good documentation is an essential part of
the quality assurance system and, as such, should be present for all aspects of
GMP. Its purpose is to define specifications and procedures for all materials
and methods of manufacture and control; To ensure that all personnel involved
with the construction know what to do and when to do it; To ensure that
authorized persons have all the information necessary to make a decision about
whether or not to release a batch of medicine For sale, documented evidence to
ensure the existence of traceability, and to provide records and an audit trail
that would allow the investigation. This ensures the availability of data
required for verification, review and statistical analysis. The design and use
of documents depend on the manufacturer.
In some cases, some or all of the documents described
below may be brought together, but they will usually be different.
Good practices in production
Principles. Production operations should follow clearly
defined procedures following manufacturing and marketing authorities to obtain
products of the required quality
Good practices in quality control
Quality control is part of the GMP concerned with
sampling, specifications, and testing, and with organization, documentation,
and release processes that ensure that the necessary and relevant tests are
performed and the material is not released for use, Nor have the products been
released for sale. Or supplies, unless their quality is considered
satisfactory. Quality control is not limited to laboratory operations only, but
must be involved in all decisions related to product quality.
1. Good Manufacturing Practices for pharmaceutical products. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations. Thirty-second report.
Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823),
Annex 1.
2. Validation of analytical procedures used in the examination of pharmaceutical materials. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical
Report Series, No. 823), Annex 5.
3. Good manufacturing practice for medicinal products in the European Community.
Brussels, Commission of the European Communities, 1992.
4. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation
Scheme (PIC/S). In: Guide to good manufacturing practice for medicinal plants,
Geneva, PIC/S Secretariat, 2000.
5.Quality assurance of pharmaceuticals : a compendium of guidelines and related materials.
Vol. 2, Good manufacturing practices and inspection. – 2nd ed.
https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf
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