What is quality control of pharmaceutical products ?
Quality control of pharmaceutical products ensures that medicines and other health products meet the quality standards required by health authorities and international standards. This includes raw materials, intermediate products, finished products, packaging materials and medical devices.
This includes various tests, analyses and evaluations targeting identity, purity, content, stability, absorption rate, bioequivalence, sterility and other critical factors such as toxicity and efficacy. Its objective is to identify quality defects, counterfeits, contamination or non-conformities and to propose appropriate corrective actions.
Performed both internally by manufacturers and through independent laboratories approved by the authorities, Product quality control also involves a European network of laboratories led by the European Directorate for the Quality of Medicines and Health Products (EDQM). This network ensures harmonisation of control practices and mutual recognition of results within the EU, thus enhancing the reliability of pharmaceutical products available on the market.
Why is quality control of pharmaceutical products important ?
Ensuring quality control of pharmaceutical products is important for several essential reasons. First, it confirms the quality, safety and effectiveness of medicines and other health products. These can have a significant impact on the health of patients if they are defective, falsified, contaminated or non-compliant.
In addition, this control is necessary to meet the quality standards imposed by national and international health authorities. These standards are becoming increasingly stringent due to the globalization of markets, the increase in counterfeiting and the emergence of new infectious agents. This process also helps to build the trust of patients, healthcare professionals and authorities in pharmaceuticals, which are subject to ongoing monitoring and accurate assessments.
Quality control is therefore a major challenge for the pharmaceutical industry, which must maintain a high level of quality for its products at every stage, from research and development to distribution and pharmacovigilance. It is also an important public health issue, aimed at ensuring patient access to reliable and effective health products and preventing health risks associated with the quality of pharmaceutical products.
Who is quality control for pharmaceutical products ?
Quality control of pharmaceutical products is essential for a wide range of actors involved in their production, distribution and use. This necessary approach includes manufacturers, laboratories, distributors, healthcare professionals, patients, as well as regulatory authorities.
Manufacturers and laboratories play a key role in ensuring the quality of medicines. For this, they perform internal quality controls at all stages of production, following Good Manufacturing Practices (GMP) and various quality standards. In addition to these internal audits, their products are subject to external controls by accredited independent entities, which ensure compliance with regulations and specifications.
Distributors, healthcare professionals and patients, as end users, must also ensure the quality of the products before use. They are required to follow storage, transport and administration guidelines, while reporting to health authorities any suspected quality incidents or adverse reactions.
Health authorities, for their part, monitor the safety and quality of pharmaceutical products on the market. They grant the necessary authorisations for placing on the market, validate compliance and supervise imports and special distributions. They also organise inspections, official controls and targeted controls in collaboration with national laboratories and the European Network of Official Drug Control Laboratories (OMCL), taking, if necessary, corrective measures to protect public health.
Which bodies offer quality control of pharmaceutical products ?
Quality control of pharmaceutical products is essential to ensure their safety and effectiveness. Many organizations participate in this monitoring and their interventions vary according to the product, its development phase, its destination and the specific requests of customers. Here is an overview of the main bodies involved in quality control of pharmaceutical products :
ANSM
The French regulatory body, the Agence nationale de sécurité du médicament et des produits de santé (ANSM), oversees the marketing of health products. Through its specialized laboratories, ANSM carries out various types of controls (biochemical, immunological, physicochemical, biological, microbiological, immunohematological) on all health products, whether they are in the approval process or already available on the market.
In addition, ANSM plays an important role in approving batches of vaccines and blood products, ensuring their safety before distribution.
EDQM
The European Directorate for the Quality of Medicines and Health Products (EDQM), an integral part of the Council of Europe, coordinates the European Network of Drug Control Laboratories (OMCL). This collaboration aims to unify control procedures and mutual recognition of analyses within Member States, thus ensuring rigorous surveillance of medicinal products on the market, whether biological, biotechnological or chemical.
Independent laboratories
Independent laboratories, accredited by competent authorities, also offer quality control services on demand. Their customers range from manufacturers, healthcare professionals, distributors and patients themselves. These laboratories offer a full range of services, including analysis of components, in-process products and finished articles, verification of analytical methods, as well as services related to quality assurance and regulatory standards.
What are the different steps in the quality control of pharmaceutical products ?
Quality control of pharmaceutical products is a precise process that is broken down into several important steps, carried out at different stages of product development. Explore below the key steps for meeting quality standards :
Raw materials control
The first critical step concerns the verification of raw materials, including active substances and excipients, used in manufacturing. It is essential to test these materials to confirm their compliance with quality standards, based on criteria such as identity, purity, content and other physicochemical parameters. Non-compliant raw materials are either rejected or quarantined.
Intermediate products control
At the heart of the manufacturing process, quality control of intermediate products ensures that they meet the quality criteria required at this stage. It includes analysis of various attributes, such as composition, purity and stability, among others. Intermediate products deemed non-compliant are either reprocessed or disposed of.
Finished products control
Before being placed on the market, finished products must undergo a series of tests to ensure that they meet regulatory quality specifications and international standards. These assessments cover a wide range of criteria, including sterility, toxicity and efficacy, thus ensuring the safety and efficacy of the products. Any finished product that does not meet these criteria is either rejected or recalled.
Packaging and labeling control
This last step ensures the verification of the quality of packaging and labelling, two crucial elements for the protection, conservation and information of the product. The tests performed aim to assess several aspects, including strength, permeability and readability, ensuring that the packaging and labels meet the required standards. Products with packaging or labelling anomalies are remedied by repackaging or relabelling.
How much does a quality control of pharmaceutical products cost ?
The price of a quality control for pharmaceutical products is influenced by various factors including the type of product, the type of analysis required, the volume of samples, the delivery time and the choice of the provider, among others. Costs can thus vary considerably.
- Product type : The complexity and nature of the product play a determining role in the cost. Biological or biotechnological products, for example, require more advanced techniques and specific equipment, resulting in higher costs compared to simple chemicals.
- Type of analysis : Fees vary depending on the analysis required. A finished product may require physicochemical, microbiological, immunological or toxicological tests, each with a cost varying according to the method and time required.
- Number of samples : The cost increases with the number of samples to be analyzed, requiring more resources both human and material.
- Lead time : A tight deadline can increase cost, due to the need to speed up the process and prioritize testing.
- Chosen provider : Prices vary significantly depending on the laboratory chosen. The laboratories can be internal, independent or official and their prices reflect their level of expertise, reputation and geographical location.
Quality control of pharmaceutical products can cost from a few hundred to several thousand euros per sample. It is crucial to compare offers and choose wisely, considering the best value for money adapted to specific needs.
How long does it take to get quality control of pharmaceuticals ?
The time required for quality control of pharmaceutical products is influenced by many factors, including the type of product, the nature of the analysis, the quantity of samples and the selected provider. Although there is no standard time limit for this procedure, a time interval can be estimated based on the following aspects :
- Product type : The complexity and nature of the product determine the duration of the quality control. Biological or biotechnological products require more elaborate procedures and advanced equipment compared to chemicals, which lengthens the quality control process.
- The type of analysis : The duration also varies according to the analyses to be carried out. The quality controls of a finished product may include physicochemical, microbiological, immunological and toxicological analyses, the time of which depends on the accuracy and method of analysis required.
- The number of samples : The more samples to analyze, the more extensive the quality control process will be, requiring more human and material resources.
- The chosen service provider : The selection of the service provider for analyses has a significant impact on deadlines. Depending on their expertise, reputation and location, internal, independent or official laboratories offer various deadlines.
As a result, quality control of pharmaceutical products can take from a few days to several months. It is crucial to learn about the deadlines offered by various providers in order to choose the one that best meets the expectations and specific requirements.
Is there a need to renew the quality control of pharmaceutical products ?
Quality control of pharmaceutical products is an ongoing process, requiring periodic updates. This renewal is driven by a variety of factors, including the nature and life of the product, storage conditions, manufacturing changes and new regulations. Renewing quality control is essential in several circ*mstances, such as :
- Market Authorization Renewal (MA) : The MA is essential to market a pharmaceutical product nationally and is awarded by the ANSM after a complete review of the product, including its quality, safety and efficacy aspects. With an initial validity of 5 years, the MA must be renewed by submitting new data to ensure that the product still meets the required standards, including the results of the latest stability tests and any changes to the production or packaging process.
- Renewal of the certificate of conformity : This document ensures that the batch of pharmaceutical products complies with the established quality standards. Issued by an independent and accredited laboratory, a new batch must be submitted for renewal for evaluation, taking into account the limited validity of the certificate, which varies according to several factors, including the nature of the product and its expiry date.
- Internal quality control renewal : Done by the manufacturer himself according to good manufacturing practices and quality standards, this control is essential at each stage of production. Each change in the production process, the material used, the raw materials or other, requires a re-evaluation to ensure that the quality of the product remains unchanged. This may include the validation of new control methods if necessary.
