INTRODUCTION:

The vendor development process refers to an organization's efforts to develop and to provide a network or linkage of qualified vendors who can meet short-term and also long-term needs. This significantly helps in identifying an effective, reliable and also in the selection of most profitable vendors for raw materials supply which is necessary for outsourcing. The selection of vendors for raw materials and production decisions is equally important.

Outsourcing can be defined as the process by which one company acquires services, goods, and products from another company to save costs and effort^1,2. An outsourcing is aimed at reducing manufacturer and supplier costs and improving customer service. It will also include collaboration between consumers and vendors in order to improve the expense of current capabilities, quality, delivery and ability and to ensure continuous progress^2,3. Vendor selection and the development of a new source of supply are an important responsibility of the purchasing department and their contribution should be accordingly planned. It has always been a difficult task for the purchasing manager of pharmaceutical industry to select the appropriate vendor. Vendor selection is an important business decision because the company with the right vendors can gain a competitive advantage to more efficiently and effectively deliver products services. Higher quality and a long-lasting relationship between buyer and supplier are more achievable if the selection process is carried out correctly^{2, 3}.

A strategic vendor actively involved in meeting the consumer's requirements by meeting all the quality-based specification requirements thereby vendors devote their own competency as well as help to improve the quality of medicinal products of the consumer’s company. Improper purchasing decision can lead to directions that can affect the quality of the product, regulatory requirements, the benefits of the organization and also the corporate status⁵. Vendors can be supplier/ manufacturer and their unit can be small, medium or large depends on the quantity of supplying raw materials, components, etc². It is easy for companies to develop a preferential strategy even more on quality, cost, and distribution service landing their geographical location, technical skills, and knowledge. The material inadequacy, quality, and cost were the major impediment that insists on the Pharmaceuticals in choosing the correct vendor. Thus, the Pharmaceutical companies maintain a narrow balance between price and quality that has a significant effect on the final drug product^{3, 4}. Manufacturers of raw materials face failures in the investigation mainly due to cGMP (current good manufacturing practices) due to non-conformance problem that may also have an adverse effect on the quality of the product. Most investigation failings are due to the lack of online documentation, implementation of guideline procedure and direction, analytical compliance, deviations, CAPA (Corrective Action and Preventive Action), an investigation into failure, cross-contamination and quality issues etc. This emphasizes the need to identify the right vendor for the production of their drug product⁷. And also, these problems may insist pharmaceutical company on selecting the alternative raw material vendors for the development of the drug products. The development of alternative vendors for materials is an essential approach by the pharmaceuticals to meet the market demand for the production of dosage forms of materials.

Benefits of vendor development:

· Helps in breaking the existing products monopoly.

· Reducing the product costs.

· Improving the product quality.

· Reaching the product’s continuous market demand.

· To keep the consumer supply of the product in time.

So when a company demands raw material, various resources will come into play. Now, the most crucial step is to select the material from the whole group of vendors to meet the required specification of the company. Current Good Manufacturing Practice (cGMP) is an internationally recognized term for controlling and managing pharmaceutical products manufacturing, testing and overall quality control. And is a part of quality assurance, which ensures the process, consistent manufacturing and product quality control in line with quality standards to be consistent with their expected use. The cGMPs (Current Good Manufacturing Practices) are guidelines for the manufacture, transportation, and delivery of a medicinal product and it is an assortment of various guidelines. Thus the action relies entirely on the FDA’s (Food and Drug Administration) program of Current Good Manufacturing Practices (cGMP) and also includes quality in manufacturing drug products. The FDA (Food and Drug Administration) rules and regulations can probably found in Title 21 of the Code of Federal Regulations (CFR). The objective is to concentrate on cGMP (Current Good Manufacturing Practices) criteria for possible risks and also offering additional attention and resources to manufacturing aspects to public health. According to current GMP (Good Manufacturing Practices) rules and regulations, the pharmaceutical manufacturer is responsible for the design activities, including component quality: the active ingredients, the excipients and the packaging materials^7,12. In systems of pharmaceutical quality, the complete cGMP (Current Good Manufacturing Practice) system is described in the guideline for the efficacy quality standard of the material are established based on ISO (International Organization for Standardization) quality design of pharmaceuticals and also their development at all phases of the product life cycle. Enforcement of quality concept includes laboratory analysis of samples and the most successful standard ISO (International Organization for Standardization) has ever released. The standard specifies QMS (Quality Management System) requirements where an organization must illustrate its ability to deliver products successfully including handling of customer complaints, services and applied legally^7,8.

METHODOLOGY:

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 the good quality of a product of 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^3,9.

The study demonstrates the requirements which can be considered for 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.

And 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 vendor⁹.

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 domain⁵.

The consumer specification requirements are given to 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:

a) Manufacturers: A manufacturer is a company that produces goods for sale in large/small quantities.

b) Suppliers: A supplier is a person, company or organization selling or disturbing customers with goods.

Preliminary assessment:

Preliminary assessment of a vendor’s organization condition starts through the questionnaire. Questionnaires include information of vendor, company, a source of material. The role of the quality assurance department is to device the questionnaires to evaluate selected vendors and analysing their response to the questionnaires⁶.

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 for or products released for sale or supply until they are quality considered to be of satisfactory.

Quality Assurance:

Quality assurance is a vast concept covers all disciplines which 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’s samples are pre-purchased. Customer service, delivery commitments, reliability, cost, and responsiveness were examined⁸.

The examination must take into consideration of a vendor’s past and 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 priorities⁵.

Analysis of pre-purchased sample:

The raw material samples are tested by 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 materials⁸.

Performance study:

Pre-purchase of samples of 3 different batches because sample 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 given specification. Based on these things quality head certifies or disqualifies the vendors. The significance in addition to raw material specifications, physical appearance variable from batch to batch to the process performance should be considered. When vendor performance potential is elevated, are principally internally focused. Vendor’s specimen must be analysed through certified standard reference materials as per pharmacopoeia methods (United State Pharmacopoeia, European Pharmacopoeia, Indian Pharmacopoeia or any other pharmacopoeia) or as per approved in-house testing procedures⁸.

QC testing:

The samples which show the effect of change must be investigated to ensure that they comply with the standard approved specification requirements and also assured 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 products 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 full fill the enumerated acceptance criteria.

Under current GMP (Good Manufacturing Practices) rules, the pharmaceutical manufacturer and the regulations are responsible for the overall operations, including quality study of Active Ingredient Component, excipients, and the packaging materials. Current Good Manufacturing Practice (cGMP) is a portion of the quality cross check which specifically assures consistency during manufacturing of product 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, general company information must be audited. 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 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 and their conformance to the vendor's certificate of analysis is cross-checked.

The questionnaire’s was drafted to assure 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, 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), with respect to manufacturing and quality cross-check aspects. All inspections are carried out by adequately trained staff or by external professionals with the aim of promoting procedural transparency and requesting 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 in accordance with the questionnaire previously prepared⁷.

Sampling of starting materials:

A sampling of materials can be derived as a procedure in which a little 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 material⁸.

Qualification and certification of the vendor by a qualified person:

Quality of material analysed based on specification compliance, zero returns due to defects in order 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 price⁸.

Vendor monitoring:

Vendor monitoring procedure is established to ensure continuous and consistent quality delivery by all vendors. This rating method is based on study of 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 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 improvement¹⁰.

Vendor rating:

Approved vendors are rated based on their performance study as per annexure which includes the description of reliability, shipment, and quality of service assessment. The rate of rejection identified based on the quality description in addition to specification conformance and null return to the defect. Availability of field assistance ratings should be 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 with respect internal resources, goal, 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 challengers exerts organizations to standardize personal proficiency and improving the respective market position, constituting them more risk doing and malleable¹⁰.

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

· Transmissible Spongiform Encephalopathy (TSE), with the notable exception of lactose.

· Excipients derived from human/animal material with potential risk of viral contamination.

· Excipients alleged to be sterile (or sold as sterile) and used without additional sterilization.

· 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 in order to avoid the potential risks listed below:

· Presence of extraneous materials such as metal, paper, particulate matter.

· Cross-contamination with excipients or APIs or breakdown products of other chemicals.

· Contamination with TSE and melamine hazardous materials 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 questionnaire, documented qualification evidence in the form of annexures detailed below (1 and 2), audit for cGMP (Current Good Manufacturing Practices), product and material stability data for at least three months¹¹.

Quality risk assessment:

Quality risk management: ICH Q9 document, which includes guidelines on cGMP must be followed in this broader context, has been developed on quality risk management guidelines. This rules and regulation precisely set out ethics and examples of risk quality tools which can be applicable to all the essential factors of pharmaceutical quality including processes development, production, transportation, and examination. And survey/permission of the whole life span of drug material substances, final products, in addition to the usage of raw materials, excipients, active ingredients, packaging and labelling materials, enabling regulators or industry to take more effective and consistent risk-based decisions. The objective of this guideline is to provide a formal approach to quality risk management and to serve just as a basis or resource, supporting other documents ICH quality and complementing current quality practices, specifications requirements, standard procedure and regulations in the pharmaceutical company and administrative condition. Understanding the risks in quality correlated among the product will allow the supply network administrator to deal more effectively with the pharmaceutical distribution. Pharmaceutical companies face a great deal of risk management throughout an organization supply network^12,13.

The Quality Risk Management described by section ICH Q9 (International Conference on Harmonization). The ICH Q9 guidance demonstrates a value-added procedure and technique for QRM. The U.S. Food & Drug Administration (FDA) possesses the same guideline document just as the resource material document. That supports and concomitant’s other International Conference on Harmonization (ICH) quality current pharmaceutical and regulatory guidance. Quality risk management (QRM) is a process which includes integration of identifying the risks in quality, risk analysis, risk cross-examination, and the development of management strategies. A few long-established QRM (Quality Risk Management) activity focus only on pharmaceutical products but ignoring the risks in quality meanwhile supply chain faces challenges in the market that ultimately lead to taking charge about the market, recollection, rejection along with administrative measures. It is a standard ideal approach of dealing with the risk of quality along with the marketing process¹⁰.

Step of supply chain quality risk management¹⁰:

· Quality risk management (QRM) was carried in production line quality professionals, whereas during pharmaceutical distribution the concept was not diligently practiced.

· The most important action in the quality management of the supply chain was to define the plans for Corrective and Preventive Action (CAPA) in feedback to identified root causes of risk for the product life cycle.

· Identify methods and procedures carried during transportation, shipping maintenance, handling and storehouse condition, environmental risk.

· Initiation of ideas and identification of root cause for the risk by other representatives of multi-disciplinary departments.

Fig1: Steps in Quality Risk Management Process.

Handling of deviation¹⁵:

It is critical to establish comprehensive procedures to describe non-conformity handling including from out of specific or out of trend handling results requiring product stream deviation during manufacturing. Procedures should be established prior to the occurrence of non-compliance when the product stream deviates from the requirement. If the material is detected non-conforming, then the next appropriate step is to discard that batch. If the monitoring in-process detects the need for material taken away a quantity of material chosen to diverted, the raw material diverted must be examined before determining the discarding of the lot. Specifications include such as analysis, testing procedures and criteria for conformance are indication of standard, quality for the medicinal product, solvents, excipients, and other substances constituents, along with containers closure systems and in-processing materials provided in the approved application given by the vendor. A labelling change in medicinal product incorporates modification in the packaging inserts, package label or container label.The environmental factors which affect the stability and also shelf life of the medicinal product are temperature, moisture, air and sunlight all these factors can affect the quality of the product crosswise all facets of the supply chain, production, storehouse and transportation of goods. A number of environmental factors directly impact on a product's stability and shelf-life, such as change in temperature, exposure to oxygen, moisture, and ultraviolet light, all of which can influence product quality across all aspects of the supply chain: production, storage, and distribution¹⁴.

CONCLUSION:

It can be concluded that it is necessary to evaluate and validate vendor before approving for supply of raw materials. By considering the Quality of the finished pharmaceutical product, proper design of specification for material and selection of the reliable vendor plays a major role in pharmaceuticals. The current state of GMP (Good Manufacturing Practices), for pharmaceutical products are adopted and monitored/inspected, in order to achieve continuous development of Quality Assurance, safety, and efficacy through greater conformity. Problems like deviation handling, quality risk assessment that arise during procurement in the pharmaceutical industry should be resolved in a timely manner or appropriately addressed on a case-by-case basis whether they are generated due to technical, personal error or misconception of guideline requirements. Vendor’s specimen should be analysed through certified standard reference materials as per Pharmacopoeia methods (United State Pharmacopoeia, European Pharmacopoeia, Indian Pharmacopoeia or any other standard Pharmacopoeia) or as per approved in-house testing procedures. Several approaches were compared and it was concluded that the reliability of the vendor should be determined periodically by the quality of the material supplied. The pharmaceutical industry should follow the medicine procurement guideline of the WHO (World Health Organisation). Supplied material specifications, testing parameters must be specified in Pharmacopoeia and accordingly the samples should be analysed. Annexure-1 includes In-house questionnaires as per good manufacturing practice requirements for raw materials. The questionnaires were prepared to assure that facility, testing, and quality management systems meet the GMP requirements and documenting the qualification evidences in the form of annexure.

Annexure-1: Pre-audit questionnaires for Raw Material suppliers [In House procedure]

Name of the Company:
Name of Parent Company:
Does your company issue an annual report with financial details? (If yes, please attach copy with sales literature and product information)				YES / NO
Address of Manufacturing Plant:
Contacts:
Telephone No:		Fax No:
Materials Manufactured:
Major customers – Local:
Major customers – Export:
1.	ORGANIZATION:
1.1	No. of employees	Production: Quality Assurance: Total on site:
1.2	Work Pattern	Shift includes: First / second / third / and general. (strike out whichever is not applicable)
1.3	Contracts for employees	Permanent / Temporary / Casual
1.4	Size of site: Age of site:
1.5	Location Urban, Rural, Industrial Please attach organization chart showing key reporting relationships. (You may enclose separate attachment)
1.6	Have you implemented a Quality Assurance system in your firm?			YES / NO
1.7	Are you ISO 9000 accredited? Other accreditations – please list			YES / NO
1.8	Is the Quality Assurance function independent of the Production Management?			YES / NO
1.9	To whom does the Quality Assurance Management Report? (please attach Quality Policy)
2.	PERSONNEL:
2.1	Are your personnel aware that the PRODUCTS SUPPLIED are used for Pharmaceuticals?			YES / NO
2.2	Do you have written training programmes for Production and Quality Assurance personnel?			YES / NO
2.3	Do you assess the effectiveness of training?			YES / NO
	If yes, please indicate how below:
3.	BUILDING AND PREMISES:
3.1	Do you manufacture the product at more than one site?			YES / NO
	If yes, please add addresses of different locations.
3.2	Does the present design prevent?
	* Chemical contamination (smoke, fumes) of other materials in the atmosphere			YES / NO
	* Physical contamination (dust, substitution, intermixtures)			YES / NO
	* Microbial contamination			YES / NO
3.3	Do you have a written general housekeeping procedure?			YES / NO
3.4	Do you have a written sanitation procedure?			YES / NO
3.5	Do you have changing/toilet refreshment facilities physically separated from production/storage areas? Please attach Site plan			YES / NO
4.	EQUIPMENT:
4.1	Are written procedures available for?
	* Set-up, maintenance, cleaning, calibration of equipment			YES / NO
4.2	Are records kept for?
	* The sequence of products manufactured on particular equipment			YES / NO
5.	MANUFACTURE:
5.1	What is your definition of a lot (or batch)?
	* One manufacturing order			YES / NO
	* One blend of raw material			YES / NO
	* A series of lots blended			YES / NO
	* What is your normal batch size?
	* In case of sterile bulk raw material give detailed explanation about one lot
5.2	Does each lot have an identifying number?			YES / NO
5.3	Are your materials used on a first-in-first-out basis?			YES / NO
5.4	Do you combine the production from more than one piece of equipment into one lot?			YES / NO
5.5	Is your production derived totally from virgin material?			YES / NO
	If not, what proportion of the feed material is from recycled material? Is the stability of such material available?
5.6	Are the finished goods are handled in a classified area?			YES / NO
	If No, where?
5.7	Do you reconcile all identity labels?			YES / NO
5.8	Do you manufacture according to a written procedure and/or custom specification for each PRODUCT SUPPLIED?			YES / NO
5.9	Are these procedures agreed by Quality Assurance?			YES / NO
5.10	Do you keep following records of each lot manufactured with respect to?
	* Equipment used			YES / NO
	* Manufacturing order			YES / NO
	* Identification, quantity and lot number of materials used			YES / NO
	* Date of manufacture			YES / NO
	* The results of in-process control			YES / NO
	* An account for any deviation from the written procedure			YES / NO
5.11	Are these records formally checked by Quality Assurance?			YES / NO
5.12	Do you have a system of equipment cleaning and clearance?			YES / NO
5.13	Is line clearance given before packing?			YES / NO
5.14	Is there a record of examination of retained samples for the products reviewed?			YES / NO
5.15	Are rejected lots or parts of lots identified?			YES / NO
5.16	Do you retain samples of each lot? If so, for how long?
	Please attach flow chart of the manufacturing stages identifying key equipment
6.	PACKAGING / DISPATCH:
6.1	Are written procedures and specifications available for?
	* Packaging components			YES / NO
	* The packing operation			YES / NO
	* Labels and labeling			YES / NO
6.2	Does the labeling procedure emphasize the special precautions needed to avoid intermixtures / substitution?			YES / NO
6.3	Do you maintain lot integrity during packaging?			YES / NO
6.4	What is your normal packaging for material of our interest?
6.5	Are you prepared to meet packaging and labeling requirements of your customers?			YES / NO
6.6	Does your labeling indicate the site of manufacture?			YES / NO
6.7	What details do you place on your dispatch labels?
6.8	At what temperature the product is stored in finished goods stores?
6.9	Are your storage/distribution facilities designed to prevent contamination of the products?			YES / NO
7.0	QUALITY ASSURANCE PROCEDURES:
7.1	Does the Quality Assurance function include?
	* Evaluation and approve the product specifications and the manufacturing procedures as well as any modification thereof			YES / NO
	* Ensuring the approved raw material / packing material is used in the manufacturing			YES / NO
7.2	Are product quality aspects considered at the design stage with respect to?
	* New equipment			YES / NO
	* New area			YES / NO
	* New process			YES / NO
7.3	Do you operate a status labeling systems?			YES / NO
7.4	Do you operate a status label reconciliation system?			YES / NO
7.5	Are samples taken by Quality Assurance personnel?			YES / NO
7.6	Is in-process control the responsibility of Quality Assurance? If not, whose responsibility is it?			YES / NO
7.8	Is there any SOP for batch record review prior to release?			YES / NO
8.	LIAISON:
8.1	Are you prepared to provide your product specifications and/or drawings to your customers?			YES / NO
8.2	Are you prepared to communicate your test methods for PRODUCTS SUPPLIED?			YES / NO
8.3	Would you welcome the discussion of quality problems with your customers and potential customers?			YES / NO
8.4	Who should be contacted in the case of any questions concerning quality? Give details:
8.5	Would you issue Certificate of Analysis / Conformance?			YES / NO
8.6	Would you notify customers of?
	* Changes in site of manufacture			YES / NO
	* Changes in manufacturing processes which affect the product quality or chemical properties			YES / NO
8.7	Is there a written procedure for holding, testing and reprocessing returned drug products?			YES / NO
8.8	Is there any written procedure for the recall drug products that ensures that responsible officials of the firm are notified in writing of the recall?			YES / NO
9.	FOLLOWING DOCUMENTS ARE ATTACHED:
9.1	Annual Report / and Sales Literature			YES / NO
9.2	Organization chart			YES / NO
9.3	Quality Policy			YES / NO
9.4	Site Plan			YES / NO
9.5	Manufacturing Flowchart			YES / NO
	Completed by:		Date:
	Signature/s:
	Designation: Department: QA