In pharmaceutical raw materials supplier selection and qualification is a lengthy and 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: Following steps should be followed for the selection of raw material supplier (manufacturer).
- Site should have 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.
- Material Certificate of analysis to check the required analytical test and its specification.
- Three different lot of sample to check the quality of material and its assessment.
- Supplier site certification i.e. ISO 9001, ISO 22000 (in case of food supplement), Drug manufacturing license, GMP certificate etc.
- Customer details
- Material manufacturing process
- Particle size of material
- TSE/ BSE declaration or animal testing certificate
- Prop65 statement
- Solvent (OVI) statement
- Material safety data sheet
- Elemental impurities and its statement
Once material and supplier site found satisfactory in all above requirement 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.Site should have supplier qualification procedure where audit criteria should be define 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 supplier 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. Agreement should defined the clear responsibility of contract acceptor and contract giver with complete details of contact information. In agreement it should be clearly defined that before making any change in process, product and facility supplier/ manufacturer should inform to the customer.All the documents like TSE statement/ Animal testing certificate/ Prop65 statement, solvent (OVI) declaration should be taken after every three year.TSE (Transmissible spongiform encephalopathy) : its a kind of disease which affect brain and nervous system of animal or human and its spread by a prion so statement from supplier is required that product does not contain any kind of animal derivative or no derivative are used during manufacturing process. if process has animal derivation then testing is required w.r.t. TSE and certificate is 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 define which can cause cancer so from the safety point of view of patient it is necessary to ensure the absence of all these chemical in material or below define level.