Internal audit quality assurance

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:

(A) All manufacturing processes are clearly defined, systematically reviewed in the light   of               experience, and shown to be capable of consistently manufacturing pharmaceutical                      products of the required standards that comply with their specifications ;
(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.

References:

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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