Date: 14/04/2026

Selecting pharmaceutical inputs in a compliant manner requires more than a purely commercial assessment of raw materials. The decision must consider evidence of batch-to-batch consistency, traceability, process control, technical documentation and the supplier’s ability to respond to audits.

In the Brazilian regulatory context, this responsibility becomes even more critical: the company holding the drug registration remains responsible for the quality of the active pharmaceutical ingredient (API) used in manufacturing. This means that supplier failures can have direct impacts on compliance, registration, production and business continuity, including in interactions with health authorities.

This responsibility is consistent with international Pharmaceutical Quality System guidelines, which assign the manufacturer ultimate responsibility for purchased materials and outsourced activities. For procurement decisions, price and unit cost are relevant variables, but the supplier’s ability to sustain regulatory compliance, predictability and documentation reliability is what reduces operational and regulatory risk in the long term.

In this article, you will find:

What regulation requires from pharmaceutical input buyers

From a regulatory standpoint, “pharmaceutical input” is not a homogeneous category. There are at least two major groups with distinct documentation requirements and control criteria: active pharmaceutical ingredients (APIs) and excipients.

APIs are substances responsible for the pharmacological action or direct effect in the diagnosis, treatment, mitigation or prevention of diseases. In general, regulations establish that the drug manufacturer remains responsible for the quality of the API used in the production process.

Excipients, on the other hand, include any components intentionally added to the formulation in addition to the active substance. Although they do not exert a therapeutic effect, these ingredients can affect stability, bioavailability, process performance and final product quality, which increases the need for technical and documentation control. Any input included in the regulatory dossier must be supported by documentation consistent with registration, audit and inspection requirements.

Health governance also includes requirements for API registration and traceability for manufacturing, import and distribution.

Aligned with international references, three requirements guide decision-making:

● Compliance with current Good Manufacturing Practices (CGMP) for APIs as a structural supply requirement;
● Controlled management of third parties and purchased materials within the Quality System;
● Data integrity as a condition to support release, deviation investigation and regulatory defense.

A secure purchase depends on the supplier’s ability to demonstrate, through verifiable documentation, what the input is, how it was produced and which controls support its compliance. Although required documents vary according to the type of input and target market, the underlying logic is the same: to reduce information asymmetry, ensuring that the buyer has access to all necessary resources to qualify the material, support registration and respond to audits and inspections.

Technical criteria to differentiate suppliers

When selecting pharmaceutical input suppliers, material complexity and clinical impact define the level of control required. The higher the criticality of the input, the greater the need to assess the supplier’s capacity to control variability, ensure batch-to-batch consistency and sustain regulatory compliance throughout the supply chain.

Four technical criteria differentiate suppliers in this process.

Risk-based impurity control

The first criterion is the ability to identify, monitor and control impurities based on toxicological and regulatory parameters.

The main areas of assessment include:

● Residual solvents, with limits defined according to toxicological risk and exposure potential;
● Elemental impurities, associated with catalysts, reagents, equipment and contact surfaces;
● Mutagenic impurities, particularly relevant due to their carcinogenic potential and the need for more robust analytical and process controls.

In this context, suppliers with more established processes demonstrate a clear risk assessment methodology, defined limits, historical data trends and investigation plans for deviations.

Definition of starting material and application of GMP

The second criterion is clarity regarding the starting material and the exact point at which Good Manufacturing Practices begin to apply within the process.

This aspect is particularly relevant in complex synthetic routes and in inputs of biological origin. The evaluation focuses on whether the supplier can demonstrate, through documentation, where critical controls begin, how upstream supply chain stages are monitored and which evidence supports input traceability.

This level of clarity reduces risk in supplier qualification and strengthens technical defense in audits.

Data integrity

The third point is the robustness of the data generated by the supplier. Analytical results only have regulatory value when aligned with data integrity practices that follow ALCOA+ principles, an acronym used to define information that is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and readily available.

In supplier evaluation, this means verifying controls over laboratory records, audit trails, computerized systems, access management and formal deviation investigations. Deficiencies in this area can compromise batch release, inspections and supply continuity.

Traceability and protection against adulteration

The fourth criterion is the ability to trace the input throughout the entire supply chain and prevent risks of adulteration, contamination or falsification. In extended supply chains with multiple logistical links and indirect suppliers, limited visibility increases exposure to origin deviations, unreported changes and compliance failures.

As a result, more structured suppliers operate with traceability systems, change monitoring, upstream partner qualification and rapid response protocols for quality events.

How MBRF Ingredients serves the pharmaceutical inputs market

MBRF Ingredients’ activities in Human Health are focused on supplying animal-origin inputs for biomedical and pharmaceutical applications. Among the main products in this portfolio is crude heparin, used as an industrial raw material in the production chain of anticoagulants widely applied in hospital settings and high-criticality procedures.

Serving this market requires strict sanitary control, raw material traceability, process stability and adherence to technical parameters compatible with subsequent purification and transformation stages of the pharmaceutical input.

Heparin: a strategic input for the pharmaceutical industry

Heparin is an anticoagulant with established use in medical practice, employed in the prevention and treatment of thromboembolic disorders and in situations requiring control of blood coagulation. The most common applications include:

● Cardiac and vascular surgeries;
● Bypass surgeries;
● Hemodialysis;
● Blood transfusions;
● Intensive care therapies;
● Prevention and treatment of deep vein thrombosis and pulmonary embolism.

The molecule also serves as the basis for the production of derivatives such as low molecular weight heparins, used in clinical protocols with more predictable pharmacokinetics.

In the industrial context, the relevance of heparin begins before final pharmaceutical formulation. Crude heparin functions as an intermediate product supplied to specialized facilities for purification, fractionation, potency control and production of the active pharmaceutical ingredient at pharmaceutical grade.

Raw material origin and initial process

In MBRF Ingredients’ operations, the raw material used is porcine intestinal mucosa, sourced from healthy animals fit for human consumption and approved by the Federal Inspection Service.

Collection takes place in a controlled industrial environment, followed by preservation in specific solutions to inhibit bacterial proliferation. The material is then transported through a dedicated system to the production facility, where it undergoes physicochemical evaluation and preliminary anticoagulant activity testing.

After initial approval, the process includes steps such as:

● Enzymatic digestion;
● Isolation;
● Initial purification;
● Impurity removal;
● Identity analyses;
● Measurement of anticoagulant activity

The resulting product is crude heparin, intended for the pharmaceutical industry for subsequent refining stages.

Industrial importance of crude heparin

Crude heparin is not intended for direct therapeutic use. Its function is to serve as the basis for the production of pharmaceutical-grade heparin. At this stage, the quality of the intermediate directly affects factors such as:

● Purification process yield;
● Batch-to-batch consistency;
● Impurity removal efficiency;
● Compliance with pharmacopeias;
● Potency standardization;
● Final drug safety.

As a sulfated polysaccharide of biological origin, the molecule presents natural heterogeneity related to chain length, degree of sulfation and structural distribution. These factors require continuous monitoring throughout the process, as they influence the efficiency of subsequent refining stages.

Traceability and control structure

MBRF Ingredients’ operations in the Human Health segment are supported by an integrated production chain, with traceability from raw material origin to the supply of the intermediate to the market. This system involves:

● Control of animal origin;
● Careful selection of mucosa;
● Dedicated and sanitized transport;
● Prevention of cross-contamination;
● Monitoring of process parameters;
● Batch-to-batch traceability;
● Specialized laboratory analyses;
● Technical evaluation of reports.

The process also includes frequent inspections and controls applied throughout industrial stages to ensure compliance with the product’s technical specifications.

Regulatory alignment and international parameters

Heparin production, from mucosa collection to the generation of the intermediate, follows controls aligned with GMP and international standards applicable to the pharmaceutical sector. Among the main standards followed by MBRF Ingredients are:

● ICH Q7 (International Council for Harmonisation – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), which provides guidance on Good Manufacturing Practices for active pharmaceutical ingredients at an international level;
● RDC 654, issued by the Brazilian Health Regulatory Agency (Anvisa), which establishes equivalent requirements within the Brazilian regulatory context, covering process control, documentation, traceability and quality.

This means that the intermediate stage must already operate under parameters compatible with pharmaceutical industry requirements, since the quality of the material obtained at this stage directly affects subsequent process steps. Even before reaching the purified API form, crude heparin must meet technical specifications that guide subsequent purification stages and compliance with global pharmacopeias.

To choose a pharmaceutical input supplier with regulatory compliance, it is necessary to evaluate how effectively this partner can support, with evidence, the quality of the material supplied and the reliability of the supply chain from its origin. This is the aspect that differentiates MBRF Ingredients’ activities in Human Health: the company’s animal-origin inputs are supported by a control structure that includes traceability, sanitary criteria and process discipline, which are critical factors for the pharmaceutical industry.

Want to evaluate in greater depth how the supply chain can influence the regulatory compliance of your pharmaceutical inputs? Contact MBRF Ingredients and learn more about the company’s Human Health portfolio.