In pharmaceutical raw materials supplier selection and qualification is a lengthy but essential process for any pharmaceutical products. Each and every raw materials (excipients, Active pharmaceutical ingredients , preservative) directly affect the quality, efficacy & safety of pharmaceutical products where it is used.So here it is important to know that how to select right supplier/ manufacturer and how to qualify the supplier before purchasing any raw materials.

Selection of raw material supplier: The following steps should be followed for the selection of raw material supplier (manufacturer).

  1. The site should have a pre-defined set of raw material questionnaire which contain all the necessary details about raw material i.e Supplier QMS control, Raw material manufacturing control, laboratory control, prevention of cross-contamination and mix-up control, etc.
  2. Material Certificate of analysis to check the required analytical test and its specification.
  3. Three different lot of samples to check the quality of material and its assessment.
  4. Supplier site certification i.e. ISO 9001, ISO 22000 (in case of food supplement), Drug manufacturing license, GMP certificate, etc.
  5. Customer details
  6. Material manufacturing process
  7. Particle size of material
  8. TSE/ BSE declaration or animal testing certificate
  9. Prop65 statement
  10. Solvent (OVI) statement
  11. Material safety data sheet
  12. Elemental impurities and its statement

Once material and supplier site(s) found satisfactory in all the above requirements then supplier audit to be done to ensure manufacturer’s site Quality management system, production control, laboratory control, material management, labeling control, engineering control, etc.

The site should have a supplier qualification procedure where audit criteria should be defined with audit standard i.e. ICHQ7, Eudralex, etc. Supplier site audit should be done for all critical excipients and active pharmaceutical ingredients as critical excipients are those excipients which directly affect the final drug product’s specification and used in large amount (>50%) in pharmaceutical products.

Re-qualification of each approved supplier is required at a defined frequency. Once suppliers approved based on the document assessment, raw material assessment, and through supplier site audit then an agreement with supplier is required before any supply of material. The agreement should define the clear responsibility of the contract acceptor and contract giver with complete details of contact information. In the agreement, it should be clearly defined that before making any change in process, product, and facility supplier/ manufacturer should inform the customer. All the documents like TSE statement/ Animal testing certificate/ Prop65 statement, solvent (OVI) declaration should be taken after every three years.

TSE (Transmissible spongiform encephalopathy): its a kind of disease that affects the brain and nervous system of an animal or human and its spread by a prion so the statement from supplier is required that product does not contain any kind of animal derivative or no derivative are used during the manufacturing process. if process has animal derivation then testing is required w.r.t. TSE and certificates are required.

Prop65: Prop65 generally called California Proposition 65 formally know as the safe drinking water and toxic enforcement act of 1986. In this regulation, a list of all the chemicals defines which can cause cancer so from the safety point of view of the patient it is necessary to ensure the absence of all these chemicals in material or below define level.