The Ultimate Guide to Choosing medical raw materials

Introduction to Raw Material Sourcing

Raw material sourcing is a critical component of pharmaceutical engineering, as it directly impacts the quality, safety, and efficacy of the final product. The pharmaceutical industry is heavily regulated, and the sourcing of raw materials is subject to stringent guidelines to ensure compliance with regulatory requirements. In this article, we will discuss the importance of raw material sourcing in pharmaceutical engineering, the regulatory requirements, and the challenges associated with it.

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Overview of the Importance of Raw Material Sourcing in Pharmaceutical Engineering

The quality of raw materials used in pharmaceutical manufacturing has a direct impact on the quality of the final product. Raw materials that are contaminated, adulterated, or of poor quality can lead to the production of substandard products, which can have serious consequences for public health. Therefore, it is essential to ensure that raw materials are sourced from qualified suppliers who can provide high-quality materials that meet regulatory requirements.

Regulatory Requirements for Raw Material Sourcing

The pharmaceutical industry is subject to various regulatory requirements, including those related to raw material sourcing. Some of the key regulatory requirements include:

• Compliance with Good Manufacturing Practices (GMP) guidelines
• Adherence to International Conference on Harmonisation (ICH) guidelines
• Compliance with regulatory requirements for supplier qualification and selection

Regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provide guidelines for raw material sourcing. For example, the FDA's guidance on supplier qualification[^1] emphasizes the importance of qualifying suppliers to ensure that raw materials meet regulatory requirements.

Challenges in Raw Material Sourcing

Raw material sourcing in the pharmaceutical industry is associated with several challenges, including:

• Ensuring supplier quality and reliability
• Managing risks associated with raw material sourcing
• Ensuring compliance with regulatory requirements
• Managing the complexity of global supply chains

To overcome these challenges, pharmaceutical manufacturers must implement effective strategies for supplier qualification, material characterization, and risk management.

Supplier Qualification and Selection

Supplier qualification and selection are critical components of raw material sourcing in pharmaceutical engineering. The goal is to identify and select suppliers who can provide high-quality raw materials that meet regulatory requirements.

Criteria for Supplier Qualification

The criteria for supplier qualification include:

• Quality management system (QMS) certification (e.g., ISO )
• Compliance with GMP guidelines
• Experience and expertise in supplying raw materials to the pharmaceutical industry
• Ability to provide documentation and certification for raw materials

Best Practices for Supplier Selection

Best practices for supplier selection include:

• Conducting thorough risk assessments of potential suppliers
• Evaluating suppliers' QMS and GMP compliance
• Assessing suppliers' experience and expertise
• Conducting audits and inspections of suppliers' facilities

The following flowchart illustrates the supplier qualification and selection process:

graph LR;
    A["Identify Potential Suppliers"] --> B["Conduct Risk Assessment"];
    B --> C{"Is Supplier Qualified?"};
    C -->|"Yes"| D["Evaluate Supplier's QMS and GMP Compliance"];
    C -->|"No"| E["Reject Supplier"];
    D --> F{"Is Supplier Compliant?"};
    F -->|"Yes"| G["Approve Supplier"];
    F -->|"No"| E;

Risk Assessment and Mitigation Strategies

Risk assessment is a critical component of supplier qualification and selection. The goal is to identify potential risks associated with raw material sourcing and implement strategies to mitigate them. Some common risk mitigation strategies include:

• Implementing a robust QMS
• Conducting regular audits and inspections of suppliers' facilities
• Developing contingency plans for supply chain disruptions

Material Characterization and Testing

Material characterization and testing are essential components of raw material sourcing in pharmaceutical engineering. The goal is to ensure that raw materials meet regulatory requirements and are suitable for use in pharmaceutical manufacturing.

Importance of Material Characterization

Material characterization involves determining the physical, chemical, and biological properties of raw materials. This information is critical for ensuring that raw materials are suitable for use in pharmaceutical manufacturing and meet regulatory requirements.

Types of Testing Required for Raw Materials

The types of testing required for raw materials include:

• Identity testing
• Purity testing
• Potency testing
• Impurity testing
• Physical property testing (e.g., particle size, density)

The following table summarizes the types of testing required for raw materials:

Test Type Description Identity Confirms the identity of the raw material Purity Determines the purity of the raw material Potency Determines the potency of the raw material Impurity Determines the level of impurities in the raw material Physical Property Determines physical properties such as particle size and density

Interpretation of Test Results

The interpretation of test results is critical for ensuring that raw materials meet regulatory requirements. Test results must be evaluated against established specifications and standards.

Risk Management and Compliance

Risk management and compliance are critical components of raw material sourcing in pharmaceutical engineering. The goal is to identify and mitigate risks associated with raw material sourcing and ensure compliance with regulatory requirements.

Identifying and Mitigating Risks in Raw Material Sourcing

Risks associated with raw material sourcing include:

• Supply chain disruptions
• Raw material contamination or adulteration
• Supplier non-compliance with regulatory requirements

To mitigate these risks, pharmaceutical manufacturers must implement effective risk management strategies, such as:

• Conducting regular risk assessments
• Implementing contingency plans for supply chain disruptions
• Developing strategies for supplier qualification and selection

Regulatory Compliance Requirements

Regulatory compliance requirements for raw material sourcing include:

• Compliance with GMP guidelines
• Adherence to ICH guidelines
• Compliance with regulatory requirements for supplier qualification and selection

Strategies for Maintaining Compliance

Strategies for maintaining compliance include:

• Implementing a robust QMS
• Conducting regular audits and inspections of suppliers' facilities
• Ensuring that raw materials meet regulatory requirements

Conclusion

Raw material sourcing is a critical component of pharmaceutical engineering, and ensuring quality and compliance is essential for public health. By implementing effective strategies for supplier qualification, material characterization, and risk management, pharmaceutical manufacturers can ensure that raw materials meet regulatory requirements and are suitable for use in pharmaceutical manufacturing.

References

1. FDA Guidance on Supplier Qualification
2. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
3. ISO : - Quality management systems -- Requirements

FAQ

What is the importance of raw material sourcing in pharmaceutical engineering?

Raw material sourcing is critical in pharmaceutical engineering as it directly impacts the quality, safety, and efficacy of the final product.

What are the regulatory requirements for raw material sourcing?

Regulatory requirements for raw material sourcing include compliance with GMP guidelines, adherence to ICH guidelines, and compliance with regulatory requirements for supplier qualification and selection.

What are the challenges associated with raw material sourcing?

Challenges associated with raw material sourcing include ensuring supplier quality and reliability, managing risks associated with raw material sourcing, and ensuring compliance with regulatory requirements.

How can pharmaceutical manufacturers ensure compliance with regulatory requirements?

Pharmaceutical manufacturers can ensure compliance with regulatory requirements by implementing a robust QMS, conducting regular audits and inspections of suppliers' facilities, and ensuring that raw materials meet regulatory requirements.

One of the major differences between research-use only (RUO) and current good manufacturing practice (CGMP)-manufactured raw materials is the quality systems in place to ensure consistency. Raw materials are reagents and/or ancillary materials used in the manufacturing of drug substances or active pharmaceutical ingredients. Because of the strong link to the final drug product, it is critical these materials meet appropriate quality standards and specifications to increase productivity, process recovery and patient safety.  

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Drugs in commercial production must be manufactured under conditions and protocols required by CGMP regulations to assure quality is built into the design and manufacturing process at every step. However, the need for CGMP supplies could begin as early as phase 1 clinical trials. Therefore, it is never too early to consider CGMP requirements during R&D or process development phases.

CGMPS: The bedrock of quality

Set regionally, CGMPs are based on guidelines developed by the International Conference on Harmonization (ICH), Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme (PIC/S) and regulatory agencies.  

These regulations are meant to assure the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. They focus on preventing cross contamination and keeping environmental contaminants out of the product in all aspects of production — from starting materials and facilities to staff training and hygiene practices. There is no CGMP certification; they are standards to maintain quality and purity characteristics in pharmaceutical development.  

Some of the most frequently referenced regulatory statements and guidelines include, but are not limited to: 

• The U.S. Current Good Manufacturing Practices for Finished Pharmaceuticals regulations (U.S. CGMPs)  
• The Guide to Good Manufacturing Practice for Medicinal Products of the European Union (EC GMP Guide)  
• MHRA Medicines and Healthcare Products Regulatory Agency 
• ANVISA Agencia Nacional de Vigiloncia Sanitaria 
• The Ministry of Health, Labour & Welfare (MHLW) Standards for Manufacturing Control and Quality Control for Drugs and Quasi-Drugs 
• The ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients  
• The World Health Organization (WHO) good manufacturing practices  

CGMP compliance during development

It is essential to consider CGMP compliance early in development rather than waiting until late clinical trials and/or large-scale production. Using well-characterized, high quality and CGMP raw materials and reagents earlier in the transition to large-scale commercial manufacturing makes for a seamless transition — maintaining quality and viability while avoiding additional costs, potential process re-development and lost production time. 

When you identify suppliers of higher quality reagents ahead of time — chemicals that have been extensively tested and documented — you gain heightened supply chain security and assurance of regulatory compliance. Use CGMP raw materials during development to: 

• Develop characterization analytics for key quality attributes (e.g., potency, purity) to ensure product consistency 
• Minimize risk of contamination or aberrant results due to a less controlled manufacturing process of the raw materials 
• Provide material traceability to support regulatory compliance 
• Eliminate requalification of material due to unavailable grade and quantity of material after technology transfer  
• Evaluate reliable sources of supply and global regulatory requirements  

Challenges of early CGMP use

The reagents needed for clinical manufacturing must meet additional regulatory requirements to validate sterility, consistency and efficacy. This includes quality control testing of incoming raw materials, increased documentation to show manufacturing control and robust process validation.  

Key challenges that early use of CGMP may address include: 

• Lot release testing. RUO raw materials do not include comprehensive (and time-consuming) quality control (QC) testing, specifically for bacterial endotoxin and particulates leading to patient safety concerns.  
• Sterility validation. With the change to GMP products, this is not a one and done test validation; dose audits must be done regularly to prove sterility per ANSI/AAMI/ISO (VDmax25).  
• Clinical comparability studies. After a raw material or process change, testing can demonstrate that there is no difference in quality of the product that could adversely impact the safety and efficacy of a product. By making the change early, manufacturers save this time-consuming process and get less chance of variants or out of specification results leading to Process Performance Qualification (PPQ) batch failures. 
• Personnel. Using CGMP reagents and equipment from the beginning builds familiarity and gets staff qualified early, reducing risk of error. 

It is important to note that any change in materials at a late stage in development, even one so benign as salt, can lead to delays, added expenses and possible process redevelopment. So, while there is increased cost in using CGMP materials early, the greater danger lies in potential scale-up issues or batch failure. 

Perils of lack of documentation

Aside from the regulatory requirement to ensure personnel authorized to release a batch have the information necessary to make decisions, it ensures all personnel connected with manufacturing know what to do and when to do it. When it comes to producing commercial biopharmaceuticals, if it’s not documented, it didn’t happen.

Documentation serves as a traceable record that a supplier’s manufacturing facility, processes and operators are fully qualified, providing a complete account of the manufacturing activities of each batch of biological product. Further, it provides an audit trail which allows for investigation should deviations occur and must allow for another person to be able to accurately reconstruct what transpired. 

Starting materials may require additional documentation on source, origin, supply chain, method of manufacture and controls applied to ensure an appropriate level of control, including of microbiological quality, if applicable. 

Key challenges that early use of CGMP materials may address include: 

• Process validation:  Supporting documentation should be in place for scale-up, providing documented proof that correct procedures are consistently followed at each step in the manufacturing process, every time a product is made. If you wait to implement CGMP materials later in the manufacturing life cycle, any variations from the validation protocol should be documented with appropriate justification. 
• Traceability: Raw materials at this level must be documented and traceable. For example, the FDA recommends keeping a record with all relevant information on all materials; including the receipt date, quantity of the shipment, supplier’s name, material lot number, storage conditions and corresponding expiration date. This ensures any issues with the end-product or process can be adequately investigated and ruled out. The traceability, proper use and storage of reference standards should be ensured, defined and recorded. 
• Certified quality systems: Documentation is not a stand-alone deliverable. Requirements for quality control sampling and testing procedures change with the transition from RUO to CGMP, as do corrective/preventative actions (CAPA). Due to the inherent variability of biological processes and starting materials, all analytical methods used in quality control should be well characterized, validated and documented to a satisfactory standard to yield reliable results. 
• Standard Operating Procedures (SOPs): Detailed, written procedures for each process that could affect final product quality are essential. Putting consistent SOPs in place takes time. Start early with CGMP materials to help maintain critical quality attributes. 

Documentation must reflect not just varying regional requirements but detail the strict procedural and environmental controls necessary for regulatory filings. The manufacturing of biologics drugs across regions governed by different regulatory bodies necessitates multi-compendial classification. Manufacturers must try to strike a delicate balance between speed and quality to meet deadlines. Proper documentation serves as a strong foundation for effective technology transfer. 

It is not a box to be checked, but should be a systematic approach to acquiring, analyzing, storing and disseminating information related to products, manufacturing processes and components. As regulatory guidance continues to evolve in a climate of accelerated and compressed timelines, risks related to process development and manufacturing increase.  

Tackling supply issues

Collaborative planning, smart forecasting and sales and operations planning are needed to keep your CGMP materials in stock to hit your manufacturing goals. This is particularly critical in the transition to commercialization, as the volume of raw materials needed will increase significantly. The importance of clear and transparent communication with suppliers cannot be understated. 

Establishing a comprehensive supply chain strategy, as well as a robust management of change program, as early as possible mitigates risk.  

Key challenges that early use of CGMP may address include: 

• Change control: Provides traceability to ensure changes were made using established processes and were evaluated for impact to the product. Changes to raw materials must be communicated from the supplier usually in the form of change management. Changes on the supplier’s side may require additional testing or revalidation of the raw materials to confirm they meet specifications. Unknown changes to critical raw materials can cause serious delays, at best. 
• Limited raw materials list: Key to building a diverse and large approved raw material parts list ahead of time, so a stable supply chain is in place with qualified secondary suppliers in case a reagent is discontinued. 
• New production/distribution sites: Moving manufacturing can disrupt a previously secure supply of CGMP reagents; facilities must be certified and in compliance with regional regulatory standards. Changing the source of supply of critical raw materials requires adherence to a formal change control system.  
• Supplier auditing: A system for evaluating suppliers of critical materials as necessary; all CGMP production materials must be traceable. This provides proactive, risk-based audits that enable manufacturers to understand the capabilities of new suppliers and collaborate effectively to promptly address CAPA, if needed.  

Business continuity and redundant manufacturing are also key parts of supply chain control. Dual sourcing can eliminate late changes in material or scale. The caveat here is to make sure both contracted suppliers get materials from truly different sources and to not use two companies that source from the same place. 

Geographic redundancy is another large risk that many companies underestimate. Specialized and proprietary materials are often located in one place, leaving them vulnerable to catastrophic events such as power outages coupled with generator failure. Any of these critical proprietary reagents should be in multiple locations for true redundancy; ideally with one version at a biorepository.   

Selection of a globally established material supplier that also has a biorepository service offers the necessary redundancies and supply chain security, such as multiple sites qualified for materials, access to new sources of materials and the ability to hold inventory in strategic geographic localities.  

Logistics risks

Using CGMP materials earlier in development simplifies technology transfer, making the transition less demanding. Developing vendor partnerships early in the design phase will improve process efficiency and minimize future errors, especially regarding quality and regulatory compliance. 

The U.S. FDA recommends a written and approved contract or formal agreement between a company and its contractors that defines in detail the GMP responsibilities, including the quality measures, of each party. This is the safest way to ensure CGMP compliance, as well as Certified ISO and ISO quality systems and animal origin-free or EMA/410/01 compliant materials. 

Key challenges that early use of CGMP may address include: 

• Supplier evaluation and monitoring. Assess their ability to meet CGMP material needs, now and in the future. Set clear expectations for product quality, including specifications for identity and purity. Make sure they have the proper analytical procedures and quality controls in place, then monitor via routine audits. 
• Multi-compendial compliance. Material portability, using standardized materials, processes and products across facilities and geographic boundaries, reduces the risk of variable quality and supply disruptions as well as program management time savings.  
• Changing environmental regulations. Manufacturers should carefully evaluate raw materials regarding regulations for environmental safety or toxicity. As compliance can vary by country or region, proactively remove or avoid at-risk chemicals to future-proof against regulatory constraints. 

To completely manage supply chain risk, choose a partner with extensive experience in manufacturing biological products and access to a broad portfolio of quality products, from multiple qualified sources. They should be able to provide all elements required for CGMP; from a qualified and trained staff and approved procedures to sterile premises and suitable storage and transport. 

Through ongoing collaboration and clear communication, developers can achieve a seamless transition to commercialization.  Designing for full GMP production at the pilot scale helps to identify and eliminate potential hurdles later and ensures quality of the product throughout its lifecycle. The upfront costs are overcome in the long term, as changes in materials can lead to process variability and potential rework of your facility, equipment and process steps. ‘The product is the process’ holds true. 

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