Vendor selection and certification is important for pharmaceutical companies to ensure quality control and regulatory compliance. It involves categorizing vendors based on risk level and monitoring them accordingly. The key steps are:
1) Evaluating vendors based on criteria like quality, delivery, facilities, financials, and compliance history.
2) Classifying them into categories from 1 to 4 based on risk, with category 1 needing minimal oversight and category 4 requiring intense monitoring.
3) Qualifying vendors through assessing processes, specifications, changes, and customer inspections to ensure quality standards are met.
4) Conducting periodic audits and follow-up visits to ensure continued compliance. This helps build confidence and trust in the vendor-customer relationship.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
• Make Versus Buy
• Benefit of Outsourcing
• Source of Supplier Information
• Strategis Selection
• Supplier Relationship Management (SRM)
• Industry Example
The Sourcing of Outsourcing Workshop This workshop is intended for delegates who are developing their sourcing strategies and techniques for outsourcing products and services, as well as those with greater experience, whose companies are in the initial years of planning and rolling out a new Outsourcing Program office. The Sourcing of Outsourcing Workshop, Ben Trowbridge, CEO, Alsbridge and William Peters, Partner, O’Melveny & Myers, sourcing, outsourcing, offshore, category sourcing, BPO
Creating an Approved Supplier Program as a Prerequisite for a Successful HACC...TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Hazards come from two places; we add them or we receive them from our suppliers.
What should we expect from an effective supplier management program? Who is ultimately responsible for the safety of the products & materials received from our suppliers? How confident are we when we justify the control of a hazard as being through our approved supplier program? What percentage of recalls is traced to supplier issues?
HACCP requires that you:
-Identify those suppliers critical to food safety and quality
-Perform a hazard assessment and define the hazards
-Identify the potential risk and significance of the hazard
-Justify our decision based on facts, scientific information and historical data
Learn how to use your existing supplier data to:
-Automatically manage supplier compliance issues
-Continuously improve supplier performance
-Better manage supplier audits
Presenters:
Debby Newslow, President, D.L. Newslow & Associates, Inc.
Presentation: Prerequisite requirement programs for successful supplier management
Gary Nowacki, CEO, TraceGains
Presentation: Automating supplier document, risk, and compliance management
Started to create milestones, we, Shreyas Chemicals marked our presence in the year 1968 and operate in the manufacturing/servicing of Pure Acids and Fine Chemicals since 45 years. Our quality services products have been always appreciated by our clients. Our spontaneous attitude and confident approach in offering an excellent range of Ammonium Sulphate, Calcium Carbonate Precipitated, Calcium Acetate Dried, Calcium Chloride, Acetic Acid Glacial, Toluene, Chloroform, Benzyl Alcohol, Calcium Hydroxide, Magnesium Carbonate Light, Sodium Nitrate has deepened our roots in the market. We, Shreyas Chemicals breathe with the aim of fully satisfying our clients with our high-quality products services. We are a unit of highly experienced professionals, all of them contributing at the best of their potentials to offer the highest degree of efficiency and client satisfaction.
The purpose of this paper is to develop a Supplier Development (SD) literature framework and identify the main focus areas in SD research. To this end, a comprehensive review of the existing SD academic literature has been undertaken, which includes 62 research papers. These papers are classified according to their research content and the research methodology employed. A comprehensive list of future research areas is also presented. Thus, this paper will also briefly explore proposed future research. The review of the SD literature presented here identifies the following main areas of focus: Supplier Development Activities, Practices and Success Factors; Direct or Indirect Supplier Development; Supplier Development as a Reactive or Strategic Process; Supplier Development in a Lean Six Sigma & SME context.
Keywords: supplier development, supply chain management, literature review
Define, select, and apply various techniques including supplier qualification, certification, evaluation, ratings, performance
improvement, and so on.
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A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
The three-day course, "Introduction to CMMI", introduces participants to the fundamental concepts of the CMMI model. The course assists companies in integrating best practices from proven discipline-specific process improvement models, including systems engineering, software engineering, integrated product and process development and supplier sourcing.
The course is composed of lectures and class exercises with ample opportunity for participant questions and discussions. After attending the course, participants will be able to describe the components of CMMI, discuss the process areas in CMMI, and locate relevant information in the model.
The workshop will help the participants to:
Understand the CMMI framework
Understand the detailed requirements of the process areas in the CMMI V1.3
Make valid judgments regarding the organization's implementation of process areas
Identify issues that should be addressed in performing process improvements using the CMMI V1.3
Auditing a vendor is truly an essential part of QMS. This presentation describes the terminologies used in vendor Audit & the way of selection, routine audi7 & approval procedure as per authority or institutional rules.
Thanks
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
Supplier Quality Assurance, often abbreviated as SQA, is a systematic approach that organizations employ to guarantee the quality and consistency of the materials, components, or services they obtain from external suppliers. The primary goal of SQA is to minimize the risk of receiving subpar products or services, which could potentially affect the quality of the final products a company delivers to its customers.
Rx-360 Mission: Protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain.
Rx-360’s Audit Programs allows companies to leverage their ever scarce resources to focus audits on the most critical and higher risk suppliers, while using a licensed audit to effectively monitor other suppliers, maintain compliance and augment their internal efforts.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
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Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
2. Content :-
2
Definition
Categories
Benefits of certification
Steps involve in certification
cGMP requirement for vendor certification
Standard procedure for conducting Quality Audit
References
3. Vendor certification is a supplier-customer partnership and can
only be successful with the full involvement and agreement of
both partners
OR
It is the combination of activities required to ensure that a
vendor will meet the professional and regulatory expectation of
the sponsor
OR
It is the system that assure that a supplier’s product is produced
under controlled condition, resulting in consistent quality
conformance
DEFINATION :-
3
5. Vendors are mainly categorized in to four different parts:-
Category – 1
Generally regarded as EXPERTS
Short lived’ in development cycle
Contracted to perform limited scope of work
Minimal monitoring
Example: Supplier customizes a formulation tank. Sponsor
reviews and approves the blueprints prior to manufacturing.
Then IQ and OQ is planned upon receipt to verify acceptability
Characteristic of vendor categories
5
6. Category – 2
Well known suppliers of standard containers ,closures ,raw
materials and excipients .
Certified to an International Standards Organization (ISO)-
9000 quality management system
Enhanced monitoring is suggested
Example: Well-known supplier of containers/closures supplies
multiple lots per year of vials to the sponsor. The sponsor has no
historical quality concerns with the supplier. Testing will be
conducted upon receipt to verify acceptability of materials.
6
7. Category – 3
Category 3 vendors may be category 2 vendors who are
experiencing quality issues with current incoming inventory or
have shown a trend of non-conformance over the last 12
months.
Can be contract laboratory operations that provide routine
analysis, sometimes in large quantities.
The risk of non-conformance of these vendors is greater than
with category 2 vendors.
Advanced monitoring program and an annual audit schedule
are recommended.
7
8. Category – 4
They are sole-source API manufactures.
Intense monitoring is suggested in this category.
Examples: A contract manufacture is supplying clinical trials
supplies. Since this is the first time that the product is being
manufactured at a larger scale, the sponsor has elected to be on
site for each event for monitoring and consultation.
100% of the lot will be visually inspected for release upon
receipt by the sponsor.
8
9. Why to qualify vendors ?
9
Used to determine if the vendor is appropriate for the scope of
work.
Critical attributes of a partner relationship are Supplier or
customer commitment to a long term relationship.
Information sharing.
Joint agreement on specifications and performance standards.
Performance measurement and feedback.
Customer confidence in the supplier’s manufacturing capability,
quality, cost, and development.
These attributes will vary depending on the status of the
supplier-customer relationship.
10. Pharma firms will then not have to carry out their own quality
audit of the vendor.
Vendors will be assured that customers of the product will not
expect to carry out their own quality audit of their systems or
products.
Rapid and efficient qualification process prior to sale and
delivery/acceptance of a system.
Reduced cost
Benefits of the Certification Process :10
11. Vendor selection criteria:-
1. Quality
2. Delivery
3. Performance history
4. Warranties and claim polices
5. Production facilities and capacity
6. Financial position
7. Price
8. Technical capability
9. Procedural compliance
10.Communication system
11.Reputation and position in industry
12.Desire for business
11
12. 13. Management and organization
14. Operating controls
15. Repair service
16. Packaging ability
17. Labor relation record
18. Geographical location
19. Amount of past business
12
13. The supplier must have suitable equipment to monitor the process.
This equipment must be routinely calibrated and test methods validated.
Statistical process control techniques will usually be applied to demonstrate
that the process remained under control, within acceptable operating ranges,
throughout each production run.
Process control data for several batches, chosen at random, should be
reviewed to confirm supplier compliance.
Process Evaluation
13
14. 14
vendor certification requires assurance that the supplier’s
process is under control and that the required quality standards
are not being achieved by inspecting out substandard material.
Increasingly, vendors are being requested to demonstrate that
their production processes are validated, especially for the
manufacture of bulk pharmaceutical chemicals.
To demonstrate commitment to quality for other components,
some vendors have opted for ISO 9000 certification. This
certification does not necessarily assure consistent quality.
15. Any proposed changes must be clearly documented, with reasons and
supporting data, and be reviewed and accepted by the customer prior to
introduction.
Some changes may require customer evaluation and even FDA approval
before acceptance Changes require, prior review and agreement with the
supplier.
For example, if the customer wants to make any replacement of a
packaging line, there would need to be discussions with the supplier of the
packaging components and the customer regarding changes
Process and Specification Changes:-
15
16. Customer Inspection
After it has been confirmed that a supplier has a controlled
process, there usually will be a period when both parties evaluate
material quality and compare data.
This provides the needed assurance that supplier and customer
have comparable evaluation ability and minimizes future
potential for disagreements that are due to test results.
Vendor certification provides a strong basis for the application of
reduced testing by the customer.
If the supplier’s process is under control, evaluation by the
customer Is necessary to evaluate any changes during shipment.
16
17. Decertification
Certification results in a high level of reliance on the supplier :
reduced incoming inspection, reduced inventories, higher output.
Any failure by the supplier for matching the customer’s
requirement , may lead to decertification of that supplier for that
material.
Depending on the nature of the problem it may be possible to work
with the supplier to reestablish certification.
17
18. CGMP REQUIREMENTS FOR VENDOR QUALIFICATION
Divided into two sections
1) Site Qualification
2) Site follow-up
Site Qualification :
Vendors selected are evaluated for compliance with the
appropriate set of regulations.
The results of the audit will be reviewed and the need for
a ‘‘site follow-up visit’’ .
Site qualification visits are generally performed on a
cyclical basis; at least once every 24 months is suggested
unless the supplier becomes problematic.
continuous monitoring program is also an essential component
18
19. BENEFIT :
Ability to evaluate the systems that the vendor uses
to produce regulated work product.
If a systems ‘‘gap’’ is detected in any of the quality systems
the sponsor should request corrective action prior to initiating
the work
RISK :
Here the systems review is theoretical, not practical
No ‘‘real’’ data can be reviewed prior to initiating the work
The systems cannot be adequately tested without ‘‘real’’ data
19
20. SITE FOLLOW-UP :
Carried out during the course of the project
Examples of issues that will usually result in site follow-up
include:-
1) Lack of adherence to standard operating procedures.
2) Lack of appropriate documentation of training, major
renovations to the physical structure of the facility.
3) If standard operating procedure (SOP) or data integrity
questions arise during the course of the study or project.
20
21. 21
BENEFIT :
Ability to evaluate the systems that the vendor uses to produce
regulated work product in ‘‘real time’’ with data generated for a
specific project
RISK :
Any corrections that may be needed will not occur in a timely
manner due to late identification of deficiencies will delay the
project
22. FACTORS TO BE CONSIDER WHEN PLANNING FOLLOW UP VISIT :
22
The relationship and experience with vendor
The extent of vendor experience with the sponsor scope of work
The sponsor’s regulatory commitments and compliance requirements
The associated risks if project fails
23. STANDARD PROCEDURE FOR CONDUCTING QUALITY AUDIT :
Standard procedures for conducting the quality audit should be addressed in the
Vendor qualification program
An audit cycle includes
1. The preparation of an audit
2. Performance of the audit
3. Reporting of the results of the audit
4. Audit closure or follow-up requirements
23
24. Step1: Preparing for the Audit
Most critical part of the audit
Takes longer to complete than performing the actual audit
By putting more time into the preparation phase, the performance of the
audit will proceed smoothly.
Effective audit plan will include the following elements:
Purpose for the audit
Scope of the audit
Resources required of the sponsor to complete the audit
Number of auditors
Type of auditor or expertise required
Assignment of a lead auditor to take responsibility for the audit.
Reference documents to be used in planning and performing the audit
24
25. Step 2: Performing the Audit
The performance of an audit begins with an introductory meeting wherein
all parties are introduced and the agenda is discussed
The performance of an audit is the collection of evidence and verification of
information through the following means:
Interviews
Examination of documents
Direct observation of activities, processes, and conditions
Review of raw data related to critical documents
25
26. Step 3: Reporting the Results
Audit report should present a summary of the results or findings
of the audit.
This includes both positive findings and any areas identified for
improvement.
Written summary prior to leaving the vendor’s facility allows the
vendor to begin working on the corrective action plans.
Formal audit report is the product of the audit.
Lead auditor is responsible for submitting the formal report in a
timely fashion.
Final audit report should be prepared within 2 weeks from the
date of the audit
26
27. Step 4: Audit Closure, Corrective Action, and Follow-Up
After audit , vendor is responsible for developing a corrective
action plan to address any weaknesses or deficiencies identified
by the sponsor’s auditors
It is the sponsor’s responsibility to ensure that the corrective
actions are effective and implemented in a timely manner
The sponsor must verify all commitments through the course of
routine monitoring
27
28. COMMON PITFALLS IN VENDOR QUALIFICATION
28
Not establishing the habit of routine update meetings
Overestimating the capabilities of the vendor
Having a false sense of confidence that the vendor will maintain
itself at the same level throughout the contractual relationship
Underestimating the resource-intensiveness of maintaining a
vendor Qualified
Not switching vendors when appropriate
Not dealing with situations of non-conformance in a timely and
effective manner
Overburdening the supplier, as though you were its only client
29. REFERANCE:-
1. Sidney H. Willing, "Good Manufacturing Practices for pharmaceuticals",
Drugs and Pharm. Sci. Series, Vol. 109, Marcel Dekker Inc., N.Y.
2. Charles A. Weber, John R. Current and W.C. Benton “Vendor selection
criteria and methods” European Journal of Operational Research 50 (1991) 2-
18 North-Holland, Faculty of Management Sciences, College of Business,
The Ohio State University, 1775 College Road, Columbus, OH 43210-1399,
USA
3. Elizabeth M. Troll, Karen L. Hughes “The Vendor Qualification Program”
(2004) CHP-10,MARCEL DEKKER Inc.
29