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Safe and Secure Supply Chain (Attributes of raw materials / chemical that…
Safe and Secure Supply Chain
Certificate of Analysis
Purpose
:
describe quality control data of a particular batch of product
Components
:
Name and Address of Certifying Body
Title of Document
(Certificate of Analysis)
Description of Material
(name and concentration)
Reference Material Code and Batch Number
Description of CRM
(information + purity)
Intended Use
Instructions for the CRM's Correct Use
Hazardous Situation
(safety information)
Level of Homogeneity
Certified Values and their Uncertainties
(Error budgets)
Traceability
(stated references)
Values Obtained by Individual Laboratories or Methods
Uncertified Values
Date of Certification
Period of Validity
Further Information
Names and Signatures of Certifying Officers
COA is
insufficient
for verifying the quality of raw materials, it can be used as a point of reference to check against. However in order to ensure the quality, tests must be conducted
Selection of Supplier
Supplier Evaluation:
List of existing suppliers with good track records
Supplier Assessment Criteria:
Equipment and Facilities
Processes
Management Capabilities
Information systems
Supplier Evaluation Criteria
Does the supplier have well-developed systems for planning material, personnel, and capacity needs? If not, why not?
Does the supplier track key performance measures, such as throughput time, quality levels, and costs? Are these measures compared to performance objectives or standards?
How easy is it for customers to interact with the supplier’s planning and control systems?
Material Supply Chain
Involves:
Manufacturers
Transporters
Warehouses (Storage)
Any party involved in the distribution, production, procurement and storage of the raw material
Materials
raw materials
components
sub-assemblies
parts
tools
consumables
services
Every organization requires raw materials and other materials for its operation that must be acquired, stored, and handled and there is always necessity for enough stocks of materials and equipment to be maintained for immediate consumption and for short and long term requirements.
A system of organizations, people, activities, information and resources involved in moving materials from supplier to customer
Supply Chain Departments
Production
:
Strategies
Validation of raw materials by doing conformity test to verify that the quality of raw materials received from suppliers
Ensure adequacy of the conformity test (e.g. test methods, sampling method and sample retention) before approval for production use
Test result stated in COA is used as reference for counter checking but not the result of the conformity test
Supplies are advised to standardize test methods used in COAs to avoid deviation in test results obtained
process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies
Procurement
:
Process of finding, agreeing terms and acquiring goods, services or works from an external source
Current Trends
the need for an alternative approach to supply chain management
supply chain integrity, security and visibility
increased focus on anti-bribery and anti-corruption
responsible procurement
greater awareness of the cost of failure to comply
Cycle:
Determine quantities needed
Reconcile needs and funds
Choose procurement method
Locate and select suppliers
Specify contract terms
Monitor order status
Receive and check medicines
Make payment
Distribute medicines
Collect consumption information
Review medicine selections
Quality
:
responsible for making sure that raw materials are provided and made into finished goods effectively.
Factors impacting cost of products due to quality:
rejected items
failure during quality testing
delays in re-work and replacement impacting production schedule
customer dissatisfaction after product delivery and warranty costs
aims of quality in supply chain
on-time delivery
cycle time for resolution of customer complaints
quality of product received by customer
supplier quality assessment major and minor findings
Attributes of raw materials / chemical that guarantee quality of drug product
contaminant free
Purity
Stability
Ensure that the properties of raw materials are fit for the manufacturing process.
Why?
Quality of the drug is highly dependent on quality of raw materials used in the drug formulation