How to Correctly Interpret Safety Data Sheets (SDS) for Pharmaceutical Raw Materials: A Guide for Drug Manufacturers

Photo: Fulvio Ciccolo / Unsplash

Safety Data Sheets (SDS) for pharmaceutical raw materials contain critical information about the properties of substances, their risks, and measures for safe handling. For drug manufacturers, the correct interpretation of these documents is essential not only for compliance with legislation such as REACH and CLP but also for ensuring the quality and safety of the production process. Incorrect interpretation can lead to contamination, improper storage, or even endangering the health of workers. This article explains which sections of the SDS to focus on, how to verify their currency, and how to apply them practically in production.

Why the Safety Data Sheet (SDS) is a Key Document for Drug Manufacturers

A Safety Data Sheet (SDS) is a fundamental document that provides comprehensive information about chemical substances and mixtures used in the pharmaceutical industry. For drug manufacturers, the SDS is essential not only from a legislative perspective but primarily as a tool to ensure worker safety, environmental protection, and the quality of final products. Under REACH and CLP regulations, every supplier of chemical raw materials must provide an up-to-date SDS in the language of the country where the substance is placed on the market. Pharmaceutical raw materials are subject to stricter requirements than common industrial chemicals – the SDS must reflect the specific risks associated with their use in medicines, including potential interactions with other substances or their impact on the stability of active pharmaceutical ingredients.

When working with raw materials, drug manufacturers must comply not only with general safety guidelines but also with specific requirements set by drug regulators, such as the European Medicines Agency (EMA) or the State Institute for Drug Control (SÚKL). The SDS thus serves as a bridge between the raw material supplier and the manufacturer, who must ensure that all processes – from storage and handling to disposal – meet strict standards. Ignoring the information in the SDS can lead to serious safety incidents, product contamination, or even the withdrawal of a drug from the market, which has a significant impact on a company’s reputation and finances.

SDS Structure and How to Correctly Read Individual Sections

The Safety Data Sheet is divided into 16 mandatory sections that cover all aspects of handling a chemical substance. For drug manufacturers, key sections include Section 2 (Hazard Identification), Section 3 (Composition/Information on Ingredients), Section 7 (Handling and Storage), Section 8 (Protective Measures and Exposure Limits), Section 10 (Stability and Reactivity), and Section 11 (Toxicological Information). Each section contains specific data that must be interpreted in the context of pharmaceutical production. For example, Section 7 describes optimal storage conditions, which can affect the stability of the raw material – incorrect temperature or humidity may lead to the degradation of active substances or the formation of undesirable impurities.

Special attention should be paid to Section 10, which deals with the reactivity and stability of the substance. Pharmaceutical raw materials often require specific handling conditions to prevent undesirable chemical reactions. For example, some surfactants or solvents may react with metal surfaces or other chemicals, which could compromise process safety. Section 11 then provides information on toxicological properties, including potential health effects from long-term exposure. This data is essential for determining appropriate protective measures for workers and for assessing risks in drug manufacturing.

Photo: Patrick Hendry / Unsplash

REACH and CLP: How these regulations affect SDS for pharmaceutical raw materials

The REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging) form the foundation of European legislation for chemical substances and their safe use. REACH requires that all chemical substances manufactured or imported into the EU in quantities exceeding one tonne per year be registered and assessed for their risks. For pharmaceutical raw materials, this means that suppliers must provide detailed data on the properties of substances, including their toxicological and ecotoxicological profiles. The SDS (Safety Data Sheet) is then the primary document that summarises and makes this information accessible to users.

The CLP Regulation ensures a harmonised system for the classification, labelling, and packaging of chemical substances and mixtures across the EU. This includes the use of standardised warning symbols (pictograms), signal words ("Danger" or "Warning"), and standard hazard statements (H-phrases) and safety instructions (P-phrases). For pharmaceutical manufacturers, it is crucial to correctly interpret and apply this information in their production processes. For example, the presence of a "Explosive" or "Corrosive" pictogram requires specific measures for handling, storage, and disposal of the raw material. Compliance with these regulations is not only a legal obligation but also a guarantee of safety and quality in pharmaceutical production.

Practical Tips for Working with SDS in Pharmaceutical Production

To effectively utilise Safety Data Sheets in pharmaceutical production, it is key to implement a systematic approach to their processing and updating. The first step is to establish an internal SDS management system to ensure that all documents are up-to-date and easily accessible to employees. It is recommended to regularly check whether suppliers have provided updated versions of SDS, especially if there have been changes in legislation or the composition of the raw material. Employee training is also important to ensure they can correctly read and apply SDS information in practice—for example, how to properly use protective equipment or how to respond in the event of a substance spill.

Another important aspect is the integration of information from SDS into internal safety and quality standards. For example, data on exposure limits (Section 8) should be considered when designing production areas and ventilation systems. Information on stability (Section 10) helps determine storage conditions and the shelf life of raw materials. Last but not least, an emergency response plan based on the guidelines in Section 6 (Accidental Release Measures) must be in place. Proper interpretation of SDS not only minimizes risks but also contributes to the efficiency and reliability of pharmaceutical production.

Photo: Ricardo Gomez Angel / Unsplash

Critical Information in SDS for Ensuring Quality and GMP Compliance

The Safety Data Sheet (SDS) for pharmaceutical raw materials is not just a workplace safety document, but also a key basis for ensuring quality in accordance with Good Manufacturing Practice (GMP) principles. Drug manufacturers must pay special attention to sections 2 (hazard identification), 9 (physical and chemical properties) and 10 (stability and reactivity), which directly influence the storage, handling and processing conditions of raw materials. For example, data on thermal stability or moisture sensitivity determine whether a raw material must be stored in a climate-controlled space or under an inert atmosphere. These requirements must be reflected in internal Standard Operating Procedures (SOPs) and validated processes.

An important aspect is also the compatibility of raw materials with packaging materials, which is often listed in section 7 (handling and storage). If the SDS states that a substance reacts with certain metals or plastics, the manufacturer must select suitable primary and secondary packaging to prevent contamination or product degradation. In the case of pharmaceutical raw materials, it is also necessary to verify whether the supplier provides an SDS with updated data in accordance with the requirements of drug agencies (e.g. EMA or FDA), which may have stricter criteria than the general REACH and CLP regulations.

How to verify the authenticity and up-to-date status of SDS from suppliers

The reliability of an SDS depends on its up-to-date status and the credibility of the source. Pharmaceutical manufacturers should require suppliers to confirm that the SDS has been prepared in accordance with current regulations (REACH, CLP) and reflects the latest classification of the substance. It is recommended to verify whether the document includes the date of the last revision and whether it corresponds to the date of the last registration of the substance in the ECHA database. For pharmaceutical raw materials, it is also advisable to request additional documentation, such as Certificates of Analysis (CoA) or declarations of compliance with pharmaceutical monographs (e.g. Ph. Eur.).

To verify authenticity, online tools such as the ECHA database can be used, where registered substances, including their classification and labelling, are published. If the SDS contains ambiguities or missing data (e.g., missing exposure limits or incomplete toxicity information), it is necessary to contact the supplier with a request for completion. For critical raw materials, such as highly potent active pharmaceutical ingredients (HPAPI), the SDS should be supplemented with specific handling instructions that are not always included in the standard document.

Integration of SDS into the Risk Management System in Pharmaceutical Manufacturing

Safety data sheets should be an integral part of the risk management system (RMS) in pharmaceutical manufacturing. Data from SDS serve as input for risk assessment according to the ICH Q9 methodology or similar approaches. For example, information on toxicity (Section 11) or ecotoxicity (Section 12) helps identify potential risks to employees, the environment, and end patients. This data must be combined with process parameters (temperature, pressure, exposure time) and evaluated to determine whether existing protective measures are sufficient.

In practice, this means that the manufacturer must define control measures based on the SDS, such as engineering controls (extraction, closed systems), personal protective equipment (PPE), or employee training. For instance, if the SDS states that a substance is sensitising, measures must be implemented to minimise contact with the skin and respiratory tract. These requirements should be embedded in internal regulations and regularly updated in line with changes in the SDS or legislation.

Do you need verified safety data sheets and expert advice?

GCG Group provides up-to-date safety data sheets (SDS) and technical support for every pharmaceutical raw material supplied. Our experts will assist you with interpreting documentation and selecting raw materials that meet all legislative and manufacturing requirements. Contact us – or browse our catalogue of over 1,300 products.