Vendor Development in Pharmaceuticals

The pharmaceutical industry plays a crucial role in ensuring the health and well-being of individuals worldwide. One of the key aspects that significantly impacts the quality and safety of pharmaceutical products is vendor development. By establishing robust relationships with reliable vendors, pharmaceutical companies can enhance their supply chain efficiency and maintain high product quality standards.

Vendor development in the pharmaceutical sector involves a comprehensive evaluation and validation process to select suppliers who meet stringent criteria for quality, reliability, and compliance with regulatory standards. This process is essential to ensure that raw materials and components used in pharmaceutical manufacturing meet the required specifications and do not compromise the safety or efficacy of the final products.

Quality assurance procedures are integral to vendor development, as they involve evaluating and approving product specifications, manufacturing procedures, and raw materials to guarantee consistency and compliance with Good Manufacturing Practices (GMP). By incorporating quality aspects at the design stage for new equipment, areas, and processes, pharmaceutical companies can proactively address potential quality issues and ensure product integrity throughout the manufacturing process.

Benefits of Vendor Development:

1. Helps in breaking the existing product monopoly.
2. Reducing the product costs.
3. Improving the product quality.
4. Reaching the product’s continuous market demand.
5. To keep the consumer supply of the product in time.

• Effective vendor development also encompasses monitoring in-process activities to detect any deviations that may impact product quality. This includes conducting thorough assessments of material stability, testing procedures, and criteria for conformance to established standards. Environmental factors such as temperature, moisture, and light exposure can significantly influence product stability and shelf life, underscoring the importance of proper storage, handling, and transportation practices.
• Furthermore, vendor development extends to communication and collaboration with suppliers to address quality problems, share product specifications, and ensure compliance with testing methods. By fostering open dialogue and transparency, pharmaceutical companies can build strong partnerships with vendors and mitigate risks associated with product quality and supply chain disruptions.

Vendor Selection Process:

• Selection and evaluation of vendors are very important for the success and service of pharmaceutical manufacturing companies. This is because the cost and quality of the sold goods and services are directly related to the cost and quality of the purchased goods and services.
• Buying and selecting vendors, therefore, play an important role in the supply chain process. The purchasing department's key objective in today's highly competitive and interrelated manufacturing environment is to purchase a good quality product of the required quantity at the right time from the selected vendors. At a reasonable price, the right source can provide the right material quality on time.
• The study demonstrates the requirements that can be considered for the vendor’s discretion and qualification procedure. The purchasing department will help in selecting the new vendor: 
• Two of the important roles of the purchasing department and quality head are: 

1. To select the right supply source. 
2. To develop a new vendor. 

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• The vendors may be large, medium, or small companies. If a raw material need is identified, then the purchasing department shall be contacted for the identification of a reliable vendor. 
• The vendor selection process begins with the design of the user requirement specification for the required materials. The pharmaceuticals are dependent on the manufacturer/supplier for the supply of materials with uniform chemical and physical properties. It is therefore important to define appropriate user requirement specifications (URS) which should be based on previous experience in the same domain.
• The consumer specification requirements are given to the material procuring department with minimal requirements: 

1. Product name 
2. Material specifications 
3. Quantity required

Qualification Process:

The Vendors are selected by the purchasing department and qualified by the quality assurance department. Vendors are classified into two types: 

1. Manufacturers: A manufacturer is a company that produces goods for sale in large/small quantities. 
2. Suppliers: A supplier is a person, company or organization selling or disturbing customers with goods.

Preliminary Assessment:

• The preliminary assessment of a vendor’s organizational condition starts through the questionnaire. Questionnaires include information on vendors, companies, a sources of material. The role of the quality assurance department is to devise the questionnaires to evaluate selected vendors and analyse their responses to the questionnaires.

Pre-purchase of sample:

• Based on the starting material specification, the purchasing department orders the material provided to them by the quality control and quality assurance department.

Quality Control:

• Quality cross-checks related to specifications and testing, and also documentation release systems to assure that the necessary and important examinations are carried out and those materials were not officially released or products released for sale or supply until they are quality considered to be of satisfactory.

Quality Assurance:

• Quality assurance is a vast concept that covers all disciplines that collectively or individually affect the quality of a product, i.e. quality management of raw materials, products, and other components, manufacturing services, management, manufacturing, and inspection processes.
• Based on the response from the vendor to the questionnaire samples are pre-purchased. Customer service, delivery commitments, reliability, cost, and responsiveness were examined.
• The examination must take into consideration of a vendor’s past and the material nature to be provided. The vendors are examined then accepted and included in the vendor approval checklist beforehand must be evaluated. The optimization and development phase of any pharmaceutical is generally governed either by Pharmacopoeia’s The evaluation procedure should be adequately justified Code of Federal Regulation 20 [CFR 20] and efficiently controlled Code of Federal Regulation 21 [CFR 21] to make stable formulation; therefore, critical quality testing parameters should be defined as priorities.

Analysis of Pre-purchased Sample:

• The raw material samples are tested by a quality control person who has responsibility for all together by collaborating in favour of other associate departments for approval of vendor’s capable of supplying raw materials Active Pharmaceutical Ingredients (API), excipients and packing devotedly it meets accepted requirements of specifications. And also verifies that the reliability of their certificate of analysis by testing and examining the pre-purchased sample as per standard testing procedure/In-house testing procedure.
• Packaging material evaluation sample procurement, handling of receipts, material sampling, release, inspection, and analysis are carried out as per standard testing procedure/In-house testing procedure and packaging materials are classified as primary and secondary, primary packing materials that come into contact directly close to the medicinal product and secondary packing materials that come into contact with primary packaging material and same degree of investigation is carried out to starting materials.

Performance Study:

• Pre-purchase of samples of 3 different batches because samples procured from the same vendor may show some changes in their physical appearance and analysis results of supplied raw material can vary from batch to batch. So three different batches of samples are procured for complete analysis as per the given specification. Based on these things quality head certifies or disqualifies the vendors.
• The significance in addition to raw material specifications and physical appearance variables from batch to batch to the process performance should be considered. When vendor performance potential is elevated, are principally internally focused. The vendor’s specimen must be analyzed through certified standard reference materials as per pharmacopeia methods (United States Pharmacopoeia, European Pharmacopoeia, Indian Pharmacopoeia or any other pharmacopeia) or as per approved in-house testing procedures.

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QC Testing:

• The samples that show the effect of change must be investigated to ensure that they comply with the standard approved specification requirements and also ensure that the change did not affect the in-process and final quality of the product. A specification is a quality standard for confirming the quality of drug material, final drug product tests analytical procedures, and acceptance criteria. Accepting criteria for the tests described are qualitative limits, ranges or other criteria. Conformance to an approved specification signifies the material will fulfill the enumerated acceptance criteria.
• Under current GMP (Good Manufacturing Practices) rules, the pharmaceutical manufacturer and the regulations are responsible for the overall operations, including a quality study of Active Ingredient components, excipients, and packaging materials.
• Current Good Manufacturing Practice (cGMP) is a portion of the quality cross-check which specifically assures consistency during the manufacturing of products and quality control of products in accordant with quality standards suitable to their deliberated use of cGMP (Current Good Manufacturing Practices), the primary objective is to reduce the risk associated with any pharmaceutical product. There are two types of such risks: cross - contamination particularly unpredicted impurities and mix-ups, for example, wrong labelling.

Pre-audit of documents:

• The particular includes all kinds of documents such as previous audit records, reports of corrective actions, internal quality, product-specific information or review of drug master file DMF (e.g. chemical synthesis), internal company guidelines and standard guidelines, and general company information must be audited.
• The vendor’s organization was consecutively audited including the quality control laboratory to check the reliability of their analytical setup quality management systems and controls to ensure that they meet the cGMP (Current Good Manufacturing Practices), requirements. The audit also verifies the reliability of their certificate of analysis by testing and examining the pre-purchased sample as per standard testing procedure/In-house testing procedure and their conformance to the vendor's certificate of analysis is cross-checked.
• The questionnaire’s were drafted to ensure that facility, testing, and quality management systems meet the cGMP requirements. This questionnaire sent to the suppliers and their responses will be examined. After completion of supplier assessment through the questionnaire, the Head of quality assurance makes a preliminary decision on vendor qualification.
• This process will be based on the adequacy of the supplier’s compliance with the general quality management system as per ICH Q7 (International Conference on Harmonisation) which will provide adequate confidence in the supply of raw materials with consistent quality.

Self-inspection:

• The self-inspection goals are evaluation and monitoring of manufacturer conformance together with cGMP (Current Good Manufacturing Practices), concerning manufacturing and quality cross-check aspects. All inspections are carried out by adequately trained staff or by external professionals to promote procedural transparency and request contributions or proposals to improve and correct the inspection regulations.
• Inspection objectives and open inspection performance questions will be discussed prior to submission of the inspection. The inspection shall be carried out by the questionnaire previously prepared.

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Sampling of starting materials:

• A sampling of materials can be derived as a procedure in which a small amount of sample is removed from each lot received from the vendor for material analysis, in consonance with a suitable practice. It is an essential practice conducted in conformance with the standard designed and authorized method suitable for the sample and the type of control intended for the sampling of material.

Qualification and certification of the vendor by a qualified person:

• Quality of material analysed based on specification compliance, zero returns due to defects to achieve the best rating, since the last evaluation a vendor must have no record of returns due to defects. Any rework history or line problems on the product of the vendor will decrease the rating accordingly. Activities such as management reviews, internal and external audits, data collection and analysis, performance measurement and monitoring, and continuous improvement through corrective and preventive actions are of key importance during this period.
• The supply source/vendor must be sufficiently qualified to ensure standard in end-product quality. In other words, it is entirely the responsibility of a company to improve the quality of its products. The core principles of procurement in the pharmaceutical industry therefore include good quality, quantity, timely delivery and the right price.

Vendor monitoring:

• A vendor monitoring procedure is established to ensure continuous and consistent quality delivery by all vendors. This rating method is based on a study of the actual delivery history of promises, quantity compared to receipt quantity, adequate packaging to avoid shipment damage, manageable in quantity and to be assessed by storage room staff, this category is intended to encourage the quality improvement of material service and vendor.
• This emphasizes the importance of identifying and understanding customer needs and expecting customers to meet their requirements. Customer satisfaction measurements are then used as feedback to assess and validate whether customer requirements have been met. The quality management review will then provide feedback to the quality head on authorization for change and opportunities for improvement.

Vendor rating:

• Approved vendors are rated based on their performance study as per the annexure which includes the description of reliability, shipment, and quality of service assessment. The rate of rejection is identified based on the quality description in addition to specification conformance and null return to the defect.
• Availability of field assistance ratings should be a collaboration between all department employees who have contact with vendors. The vendor is mainly focused once accomplishment disposition is a high rise, the company is determined concerning internal resources, goals, building infrastructure, and set-up and their external environment does not drive them as much in terms of action impetus.
• A culture of competitiveness is more external or focused on the market. Competitive firms prioritize marketplace achievement, quality emphasis, and distinguishing themselves from the competition. Focusing on exterior challenges exerts organizations to standardize personal proficiency and improve their respective market position, making them more risk-taking and malleable.

Qualification requirements for raw materials and packing materials:

• Current status of GMP (Good Manufacturing Practices), for pharmaceutical excipients: Many regulatory agencies have provided APIs with GMP guidelines. Unlike APIs, excipients are least monitored by regulators. In the U.S., the FDA is responsible for enforcing 21 CFR Parts 210 and 211 requirements for the manufacture of drug products from APIs, excipients, and other components. The agency has published numerous guidance documents on the manufacture of drugs over the years.

• Excipients are an intrinsic part of almost all medicinal products and thus have an impact on drug products ' quality, safety, and efficacy. The transition from excipients perceived as inactive, inert ingredients to the current status of pharmaceutical excipients is well underway. Excipients made from materials derived from the relevant animal species of

1. Transmissible Spongiform Encephalopathy (TSE), with the notable exception of lactose.
2. Excipients derived from human/animal material with potential risk of viral contamination.
3. Excipients alleged to be sterile (or sold as sterile) and used without additional sterilization.
4. Specification excipients or claims to be controlled by endotoxin/pyrogenic.

• Vendor qualification is required in addition to the above-mentioned cGMP (Current Good Manufacturing Practices), regulatory expectations, and requirements, the excipient vendor qualification is particularly important to avoid the potential risks listed below:

1. Presence of extraneous materials such as metal, paper, and particulate matter.
2. Cross-contamination with excipients or APIs or breakdown products of other chemicals.
3. Contamination with TSE and melamine hazardous materials is not permitted by legislation.

• This overview highlights the importance of pharmaceutical excipient manufacturer’s cGMP (Current Good Manufacturing Practices), and vendor qualification for drug product safety, quality, and efficacy. The above approach is expected to be a useful tool for quality assurance staff that is in the process of implementing a vendor qualification system in general and pharmaceutical excipient manufacturers in particular. Certification criteria should include a questionnaire, documented qualification evidence, an audit for cGMP (Current Good Manufacturing Practices), and product and material stability data for at least three months.

In conclusion, vendor development is a critical component of pharmaceutical supply chain management that directly impacts product quality, safety, and regulatory compliance. By implementing stringent vendor evaluation processes, quality assurance procedures, and effective communication strategies, pharmaceutical companies can enhance their overall quality management practices and ensure the delivery of safe and effective products to consumers.

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