Perhaps one of the single most crucial decisions for a pharma company can be the selection of an API supplier. This, by itself, cannot be viewed as a ‘simple commodity purchase’, as it cannot escape from product quality and impacts, on the basis of the characteristics and requirements of the drug product of quality, consistency, control and tractability from within a controlled manufacturing processes and systems. Quality, in consequence for this consideration has come to have a major effect as to the decision Making.
By pharmaceutical companies, quality has become a key element, coupled now with aspects of: manufacturing capability; supported by documented evidence; the suppliers regulatory track;; history, and supply integrity and also product quality management systems.
The fundamental criteria for this evaluation have been provided by aspects of regulation and ICH Q7, which gives GMP criteria relevant to API manufacture, and guides the alignment of these systems and factors to address API quality attributes and ensure suitability, and an agreed level of quality, and purity criteria as part. The API supplier who offers the product at, for instance, the cheapest price, should not be favoured as a favoured partner if they cannot provide a consistent, guaranteed quality product and appropriate commercial and regulatory back up when needed.
What Does Regulatory Compliance Mean for an API Supplier?
Regulatory Compliance (RC) means abiding by the laws, regulations, standards and quality guidelines applicable to pharmaceutical manufacture and supply chain activities. For an API manufacturers this can include starting materials receipt and handling, their own production, quality control and product specification, packaging, warehousing, shipping etc.
ICH Q7 clearly specifies the elements that relate to these areas under its GMP guidelines.
RC shouldn’t just be a certificate on the wall;it requires established written procedures and process documentation, qualified staff, adequate and controlled process infrastructure, effective testing, quality investigations and quality oversight, and appropriate batch and supply chain tracking etc. However the actual RC will differ greatly for a drug on a European market verses North American market,for use in an ‘essential use drug versus novel biological,’ or for a API used solely in veterinary drugs and so the buyer should tailor their check against their own target market, use and quality parameters.
Why Compliance Matters in API Supplier Selection
Compliance-This is the ability to determine if a potential supplier is capable of the systems to manufacture a constant quality of material.
A qualified supplier can reduce the risks associated with:
* Unforeseen changes in material quality
* Inadequate documentation
* Undocumented process changes
* Undocumented contamination and cross-contamination
* Loss of traceability
* Disruptions in supply
* Regulatory problems
The FDA Q7 guidance recommends that the process of supplier approval include verification that the manufacturer is capable of providing material of the required specifications on a reproducible and consistent basis and lists annual review of the reliability and Certificates of Analysis of suppliers.
This makes obvious why supplier qualification should be based on evidence, not on the marketing efforts of the supplier.
GMP and Quality Management Systems
The quality management system should be one of the key factors to assess a GMP compliant API supplier.
An effective quality management system might comprise of:
Standard operating procedures
Training of personnel
Batch manufacture records
Laboratory controls
Change control
Deviation investigations
CAPA
Internal audits
Equipment qualification
Process validation where appropriate
Complaint handling
Product quality review
The quality function should possess sufficient independence and responsibility. Examples include the review and approval of quality documents, approval of specification, the investigation of critical deviations, and approval or rejection of APIs.
By scrutinising these systems, a buyer of pharmaceuticals may develop a greater appreciation of how a supplier controls quality in their operations.
The Importance of API Documentation
It all matters in Supplier qualification One of the biggest items in APi supplier qualification is Documentation. A buyer might need: Certificate of analysis Product specifications Safety Data Sheet Manufacturing data The process description Analytical data and/or methods Data on stability or retest Date of Manufacture Material Identification Data (for traceable items) Relevant certifications on packaging Regulatory documents Documentation provides ability to the customer to check incoming material against desired specifications, and keep adequate documents. FDA states that reliable Certificate of analysis and sound documentation are essential to the effective establishment and use of robust supplier evaluation process for API manufacturing and suppliers can have significant impact in API manufacturing. Documentation is vital for international companies that need to meet specific requirements for their importing country as they might be different from their home countries.
Supplier Audits and Qualification
Many pharmaceutical companies will visit supplier sites prior to agreeing to contract a new source for an API. As you can see from a site audit you can assess the reality of their system, instead of relying on paperwork alone. For a typical review you might consider:
MANUFACTURING :
Are manufacturing systems correctly documented and controlled?
QUALITY CONTROL
Is their laboratory set up with the appropriate testing procedures and controls in place?
QUALITY ASSURANCE
Is their process for managing deviations, changes, complaints and CAPA well-documented and controlled?
TRACEABILITY
can batches and relevant manufacturing records be linked?
FACILITIES & EQUIPMENT
are the critical equipment and systems adequately maintained and qualified?
PERSONNEL
are the staff suitably trained to conduct their roles?
are the staff suitably trained to conduct their roles?
I should also point out that ICHQ7 says companies should assess contractors when they perform certain operations onsite.
Certifications Are Important—but Not the Whole Story
While accreditations, certifications, audit history and approval may offer insights into the capabilities and reliability of a potential supplier, Buyers must confirm the scope and currency of these qualifications, as well as the credentials of issuing agencies and their relevance to the products and services offered. A simple certificate is not sufficient without qualification of the supplier. Companies involved in Pharmaceuticals must review the entire value chain – including manufacturing controls, quality systems, product testing, record keeping, regulatory record and the past performance of the supplier. This becomes particularly significant when evaluating suppliers from different regions of the world, serving varied global regulatory environments.