This document discusses general requirements and standards for materials used in the production of biological products. It covers topics such as starting materials, packaging materials, finished products, waste materials, reference standards, and documentation requirements. Maintaining appropriate storage conditions, purchasing controls, labeling, and record keeping are important across all material types to ensure quality and prevent mix-ups or contamination. Reference standards must be stable and available in sufficient quantities to allow testing over several years and ensure uniformity and reliability of results.

1. Materials/Standards Supaporn Phumiamorn Division of Biological Products GMP course, 17-18 Jan, 2006

27. Calibration System WHO: Calibration is generally achieved by parallel titration on at least six separate occasions. NCL: Calibration is routinely performed at least six times by at least two persons. (2 NCL labs + Manufacturer lab)

28. Calibration of WRP for Total OPV (Measles, Mumps, Rubella)

29. Parallel line assay Response Dose Parallelity Linearity 95% confidence limit Probit analysis (JE, Rabies ,Hepatitis B, Pertussis vaccines)

30. Reference Standard materials assuring the uniformity of the testing results assuring the reliability of the testing results

43. Warehouse check list Identification of all customers Records of storage: time, temperatures Records of date, quantity, mode of packaging Distribution to customer SOPs for storage of released products

44. SOPs for warehousing SOPs for shipping, final transit conditions and storage Validation and monitoring of shipping methods Recalled Maintenance of records for 2 years beyond Expiry date