In one incident, the use of an unsuitable RM led to widespread toxicity, resulting in hallucinations and other severe symptoms. For example, the accidental use of ethylene glycol instead of propylene glycol resulted in morbidity and mortality. Legally, a pharmaceutical firm takes on full responsibility for the quality of the RMs it purchases and uses in a cGMP manufacturing process.

Consequently, it is in the business interest of a firm to exercise reasonable oversight of suppliers and test laboratories and to characterize RMs appropriately. Regulatory requirements in the pharmaceutical industry have evolved over time to reduce the probability, or risk, of such events.

Some of the most important actions a firm takes to reduce risk include setting specifications that define and control the RMs, testing to verify identity and quality, and establishing systems to prevent the use of unsuitable materials.

RM qualification should be carefully defined in GMP procedures and placed under strict change control. Both the chemical entity and suppliers must be qualified, usually in tandem.

RMs deemed "critical" require testing of more supplier lots for more attributes and extensive supplier evaluation before qualification is achieved.

The critical status of an RM is related directly to its intended use in the process and to the potential risk created by a quality deficit in the RM that may adversely impact the product's identity, purity, potency, toxicity, or efficacy.

Each firm must identify which materials are critical and justify the choices made and the additional oversight required. Table 1 summarizes the applicable regulations for pharmaceutical products of various types, and summarizes some of the differences between US and European regulations.

These differences may create complex challenges for the firm that manufactures multiple profile classes of products for worldwide sale. Considering the rapid rate of change to these regulations, sustaining a compliant, effective program requires a strategic approach.

A firm faces the practical challenge of establishing and operating an efficient, compliant system that assures continuous supply of quality RMs that are sampled, tested, and then released for manufacturing needs on time.

A properly sized and managed warehouse provides a buffer zone where unpredictable RM problems back orders, late deliveries, and items failing to meet specifications can be resolved without delaying manufacturing.

However, it is undesirable to build large warehouses and store huge inventories if materials must be discarded because they expire before use. Therefore, it is important for supply chain management to reduce the probability of receiving RMs that fail to meet specifications.

This is part of the payoff of a robust and sustainable vendor and RM qualification program. Business needs. In establishing an RM qualification program, first determine your internal business requirements. A development organization will usually need a rapid, flexible RM qualification process that can quickly assess up to or more new materials and suppliers and approve them for at least provisional use.

Furthermore, changes in RMs and suppliers are expected during development. In contrast, an organization with a mature, marketed product is unlikely to have frequent changes in RMs, and long-term supplier relationships are commonly in place.

Any changes may require overcoming regulatory hurdles and are highly undesirable. Consequently, all RMs are likely to be fully qualified before use and the quality program will focus on maintenance and monitoring of the qualified state.

System procedures. In order to qualify new RMs from new or existing suppliers, several GMP procedures and systems are needed see Table 2. In writing these procedures, consider compliance as well as efficiency. Check that the different documents link with each other appropriately and do not contradict each other.

Avoid the extremes of lumping many procedures into one document or splitting integrated procedures into different documents. Check that the procedures are clearly written and can be consulted and followed while on the floor.

A master plan is an invaluable document for both new and existing programs. This document may be "live" subject to periodic revision or static created at one moment in time. Some firms archive master plans within a quality manual, while others place the information within a standard operating procedure.

A master plan records basic decisions and assumptions, codifying company philosophies and corporate policies related to quality. Since the document is kept centrally, it can be used to archive organizational history, assumptions, and knowledge. It will be retrievable long after meeting minutes are lost, and can be cited by other documents.

The master plan can include references, discussion of any interpretation issues, and the company's formal commitment to quality.

Creating a master plan has a further, indirect benefit. By documenting key assumptions, roles, and responsibilities, cross-functional dialogue occurs and team members can improve their alignment, engage in continuous improvement, and better understand their customers' needs.

Inconsistencies in the strategy or gaps in team assignments are exposed and can be addressed before issues arise. Table 3 lists typical sections of a master plan.

This information also may be captured in other documents, such as quality manuals or system SOPs. Regardless of the document's name, be sure that it is linked to cGMP systems and the information is accurate, archived, and traceable.

Quality concerns. The program also needs to have built-in responses when quality issues are discovered by QC testing or by QA audits. One common disconnect, particularly in firms where QC and QA are each part owners of the RM control system, is that the system does not respond quickly to new information.

Similarly, an appropriate response to adverse audit findings may include increased QC testing and an adjustment in the frequency of follow-up audits. To make this happen reliably, the nonconforming materials control system, the audit program, and the RM testing programs must include linkages and notifications.

A review of several FDA warning letters and s issued to firms at the end of inspections , suggests that some firms' systems are not sufficiently agile to respond to new RM issues in a timely way, creating compliance risk and negative findings.

Table 4 summarizes recent deficiencies that were cited by FDA from to Process thinking is especially helpful in setting up the system for RM and supplier qualification.

Often, a specialized team member conducts a single step in the qualification process and then hands off the data to the next team member. Process engineers know that errors and miscommunications occur at interfaces between people and organizations; compliance auditors tend to look for deficiencies at these points.

Therefore, creating a committee of key members involved in RM processes facilitates communication, helps ensure that information is not lost or garbled during transfers, and establishes a structure that can handle RM non-conformances. Figure 1 shows a flow chart for the RM qualification process.

The tasks listed are documented in and driven by SOPs or other GMP documents. Depending on the organization, several different work units such as QC, purchasing, shipping and receiving, manufacturing, and QA may participate. Both the quality and manufacturing units approve suppliers and RMs.

However, in order to maintain objectivity and minimize conflicts of interest, regulations require that the quality unit has oversight and the sole authority to disposition RMs for release or rejection. The following elements should be part of an RM qualification exercise.

Note that some steps may be combined and several are concurrent. Step 1. Collect information regarding the RM: What grades are available, and what do suppliers test for and set specifications upon?

Is the material listed in a compendium such as the US Pharmacopeia, European Pharmacopeia, or Japanese Pharmacopeia? Compendial materials are well defined and accepted as suitable for finished pharmaceutical use. Is this RM critical or noncritical, based on its intended use?

See Table 5 for examples of critical RMs. Step 2. Determine the qualification strategy and set your acceptance criteria for this RM. The purpose of qualification is to generate evidence that your firm can rely on the supplier's certificate of analysis and start defining the quality profile of the RM.

The quality profile includes those chemical, biochemical, or microbiological characteristics consistently possessed by the RM and those attributes required by your process. Therefore, it may extend beyond those tests reported on the certificate of analysis. Your email address will not be published.

Save my name, email, and website in this browser for the next time I comment. The Importance of Good Quality Raw Materials in Pharmaceutical Manufacturing. Introduction Pharmaceutical manufacturing is a complex process that involves several stages and requires the use of raw materials to create drugs that are effective and safe for consumption.

The Risks of Poor Quality Raw Materials Raw materials are the building blocks of any drug and if they are of poor quality, the final product will also be of poor quality. Using low-quality raw materials can have serious consequences, including: Adulteration of the final product Decreased effectiveness of the drug Increased risk of contamination Inconsistent drug formulations In order to minimize these risks, it is crucial that only high-quality raw materials are used in the pharmaceutical manufacturing process.

The Benefits of Good Quality Raw Materials The use of good quality raw materials in pharmaceutical manufacturing provides several benefits, including: Improved drug efficacy and safety Consistent drug formulations Reduced risk of contamination Increased patient confidence in the drug The improved reputation of the pharmaceutical company By using high-quality raw materials, pharmaceutical companies can ensure that the drugs they produce are effective, safe, and consistent, thereby improving the overall quality of healthcare.

Factors to Consider When Selecting Raw Materials There are several factors that pharmaceutical companies should consider when selecting raw materials for their manufacturing process.

These include: Quality of the raw material Purity of the raw material Origin and authenticity of the raw material Compliance with industry regulations and standards Cost-effectiveness of the raw material It is important for pharmaceutical companies to conduct thorough research and due diligence when selecting raw materials, in order to ensure that they meet the necessary standards and regulations.

The Importance of Stringent Quality Control Measures In addition to selecting high-quality raw materials, it is also important for pharmaceutical companies to implement stringent quality control measures in their manufacturing process.

These measures include: Regular testing and inspection of raw materials Implementation of Good Manufacturing Practices GMP Documentation and traceability of raw materials Use of validated methods for testing and analysis By implementing these measures, pharmaceutical companies can ensure that the raw materials they use are of the highest quality and meet the necessary standards and regulations.

Frequently Asked Questions Q. Conclusion: The Importance of Good Quality Raw Materials in Pharmaceutical Manufacturing cannot be overstated. Share Blog on Social Media.

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Many leading pharmaceutical corporations are now focusing on pellet manufacturing by using various medication formulation development procedures. A lot of factors influence pellet formulation. The creation of formulation is based on multiple unit control dosage forms, which aid in the uniform distribution of the active therapeutic material in the human body.

Pharmaceutical companies manufacture pellets for various applications. These pellets are often utilized for developing oral controlled-release dosage forms with gastro-resistant or sustained-release features. Furthermore, they have the ability to deliver drugs to a specific site.

Pharmaceutical intermediates are chemical compounds that are frequently employed in the mass production of many types of drugs.

Pharmaceutical and biopharma businesses also use them in research and development. The Pharmaceutical intermediates form the building blocks of APIs and they are the by-product during the production of APIs. Therefore, every reaction gives rise to a different range of intermediates.

Pharmaceutical intermediates are also known as fine chemicals created as intermediary molecules while manufacturing active pharmaceutical ingredients APIs. Intermediates are byproducts of the reactions that occur throughout the API manufacturing process. Nutraceutical products are non-specific biological medicines that are used to increase overall well-being, manage symptoms, and prevent cancer.

The definition of nutraceuticals and associated items varies according to the source. These goods can be classed according to their natural origins, pharmacological conditions, and chemical composition. Nutraceuticals are often classified into four categories: dietary supplements, functional foods, medical foods, and pharmaceuticals.

A dietary supplement is a product that contains nutrients taken from food and is frequently concentrated in liquid, capsule, powder, or pill form. Although dietary supplements are regulated as foods by the US Foods and Drug Administration FDA , their regulation differs from that of pharmaceuticals and other food items.

Therefore, there are different types of pharmaceutical materials available for different uses. This blog will help you understand more about them. The other main ingredients are the inactive compound, known as excipients.

These are often used as the API carrier in the next medication.