Pharmaceutical raw materials – a guide to ingredient selection and quality control

The selection of appropriate pharmaceutical raw materials is the foundation of the effectiveness and safety of the final product—whether a medicine or a dietary supplement. How should these ingredients be selected and controlled? We provide the answers.

What Are Pharmaceutical Raw Materials and Why Are They So Important?

Pharmaceutical raw materials are substances used to produce medicines and dietary supplements. Their quality directly affects not only the effectiveness but also the stability and safety of the final product. These materials determine how a drug or supplement will interact with the human body.

Active and Excipients – Differences and Applications

Pharmaceutical raw materials include active substances (Active Pharmaceutical Ingredients, API), which have a direct effect on the body and are responsible for the action of the medicine or supplement.

They also include excipients, which do not have therapeutic properties but serve to:

• give the final product a specific taste or color;
• ensure the stability of the medicine or supplement;
• facilitate absorption of the active ingredient and/or ease of administration.

Classification and Origin of Pharmaceutical Raw Materials

Pharmaceutical raw materials can be of natural, synthetic, or biotechnological origin.

Natural raw materials are extracted from various parts of plants and used in herbal medicines and dietary supplements. Although better accepted by patients, due to variability and risk of contamination, they require proper standardization.

Synthetic raw materials are produced in laboratories through chemical reactions. They are often more stable analogs of natural substances. Because they are highly pure and can be produced at scale, most modern medicines are based on synthetic raw materials.

Biotechnological raw materials are derived from living organisms (e.g., bacteria or yeast) using genetic engineering and biotechnology. These are often better suited to the human body and effective in smaller doses. However, their production is complex and expensive, sensitive to storage conditions, and requires strict quality control.

Selecting Raw Materials for Drug and Supplement Production – Key Criteria

Careful selection of raw materials—both active and excipients—is a critical element in pharmaceutical production.

The most important criteria for manufacturers and distributors of pharmaceutical raw materials include:

• purity – any contamination, e.g., chemical or microbiological, can negatively affect product quality and safety;
• standardization – especially important for plant-based raw materials. Standardization ensures consistent active ingredient content and predictable results;
• bioavailability – even well-studied raw materials may be ineffective if poorly absorbed by the body;
• chemical and physical stability – directly impacts the shelf life of the final product.

Quality Control of Pharmaceutical Raw Materials – Standards and Procedures

Quality control of pharmaceutical raw materials is a complex process aimed at confirming that each ingredient meets established standards and is safe for further use.

This includes steps such as:

• documentation verification – including Certificates of Analysis (CoA) and MSDS (Material Safety Data Sheets);
• review of procedures – e.g., HPLC (High-Performance Liquid Chromatography), TLC (Thin-Layer Chromatography), mass spectrometry;
• laboratory tests – testing purity, measuring active ingredient content, detecting contaminants (e.g., heavy metals);
• physicochemical assessment – including color, odor, texture, and solubility.

Additional microbiological tests are required for natural or biologically sourced materials.

The Role of Suppliers and Quality Certificates in Pharmaceutical Manufacturing

In the pharmaceutical industry, final product quality heavily depends on the standards upheld by both distributors and suppliers of raw materials.

Choosing the right business partner is essential for patient safety. That’s why supplier audits play a crucial role. These audits may include:

• assessment of manufacturing processes;
• evaluation of quality control procedures;
• review of raw material storage, packaging, and labeling;
• compliance verification with pharmaceutical law and standards such as GMP and ISO standards.

Examples of Controversial or Problematic Raw Materials

One of the biggest threats related to pharmaceutical raw material quality is contamination with heavy metals such as lead, cadmium, or mercury. These can enter plant-based raw materials from soil, water, or air, and even in small amounts, may lead to serious long-term health issues.

Raw materials with low bioavailability are also problematic, as they are less absorbed by the body. Without appropriate technologies, even high doses may have minimal clinical effectiveness.

At Eubioco, we have been providing top-quality products and services for over 30 years. Our production of medicines, dietary supplements, and cosmetics is carried out in accordance with Directive 2003/94/EC and Good Manufacturing Practice (GMP), as defined in the Polish Ministry of Health Regulation of November 9, 2015 (Dz.U. 2015 poz. 1979). We operate a modern laboratory where production processes are continuously monitored at every stage, in compliance with the HACCP Quality Management System. Cooperation with Eubioco ensures safety and top quality of the final product—which is critical in the pharmaceutical industry.

Pharmaceutical Raw Materials – Frequently Asked Questions

I. What are pharmaceutical raw materials?

They are substances used in the production of pharmaceutical products (medicines and supplements).

II. What are the quality criteria for raw materials in dietary supplements?

Key quality criteria include: bioavailability, purity, stability, and standardization of active ingredient content.

III. How do pharmaceutical raw materials differ from food-grade materials?

Pharmaceutical raw materials must meet far more stringent standards of quality and purity than those used in the food industry.

IV. How is ingredient quality controlled in a pharmaceutical company?

This may include document verification, laboratory tests, physicochemical evaluation, and compliance with GMP and ISO standards.

V. What certifications should a raw material supplier have?

Suppliers should be able to provide certificates such as CoA (Certificate of Analysis), MSDS, GMP, and ISO.

VI. What does standardization of an active ingredient mean?

It ensures each batch of raw material contains a consistent and specified amount of active substance.

VII. Are all natural ingredients safe?

No – some natural pharmaceutical raw materials may be contaminated with heavy metals, pesticides, or fungi, which can affect their safety and effectiveness.

VIII. What are the most common mistakes when selecting raw materials?

The most common mistake is purchasing pharmaceutical raw materials from unverified suppliers.

REFERENCES

1. Kumar, V. et al. (2022). Active pharmaceutical ingredient (API) chemicals: a critical review of current biotechnological approaches. Bioengineered, 13(2), 4309–4327. https://doi.org/10.1080/21655979.2022.2031412.
2. Li, C.-Q. et al. (2021). Recent Advances in the Synthetic Biology of Natural Drugs. Frontiers in Bioengineering and Biotechnology, 9. https://doi.org/10.3389/fbioe.2021.691152.
3. European Medicines Agency (2024). Good manufacturing practice [online]. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice [accessed: 25.04.2025]