Reserves sampling

For an active ingredient in a drug product other than those described in paragraphs (a) (2) and (3) of this section, the reserve sample shall be retained for... 

For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient. 

Code of Federal Regulations, Title 21, Food and Drugs, Part 211, Current good manufacturing practice for finished pharmaceuticals, Subpart I, 211.170 Reserve Samples. 

A specific statement then is given that requires that a reserve sample be retained for all required tests and that it should be available for at least 2 years after distribution of the last drug lot that utilized the components or 1 year after a stated expiration date of the finished product. 

The laboratory should maintain the master records for all lots of incoming raw material as well as finished product. Samples should be retained by the laboratory for immediate identification or future reference, which constitutes a reserve sampling system... 

This section also concerns itself with the ability to review laboratory test procedures and laboratory instruments used. It is stressed that reserve samples of marketed products must be retained in their original containers for at least 2 years after the final distribution of a lot or at least 1 year after the drug s expiration date. In this same light, laboratory data for each batch or lot of drug should be retained for these time periods... 

The FDA has indicated that study initiation date (defined in 58.3(e)) and study completion date (defined in 58.3(p)) are administrative dates and should not be used to determine whether or not a study is of more than 4 weeks duration. Instead, terms-of-the-art (e.g., 14-day acute study, 28-day repeated dose study, etc.) will determine whether reserve samples are required under 58.105(d). 

Reserve sample size should be at least twice the quantity necessary to perform ah tests to determine whether the... 

As shown in Tables 6-8 the Indian GMP regulations consists of eight parts I, IA, IB, IC, ID, IE, IF, and II. Part I covers the general requirements of GMP. It is divided into 29 chapters, which deal with the requirements for personnel, premises, equipment, sanitation, production and process controls, materials, documentation, quality management, validation, reserve samples, recalls, complaints, and self-inspection. Parts IA to IE cover specific requirements for the manufacture of different dosage forms regarding premises, equipment, and methods. Part IA deals with the require-... 

Additional guidelines outline the need for reserve samples [33], expiration dating [34], and laboratory recordkeeping [35]. 

Representative samples of each shipment must be collected for testing as required by 211.84. (b). The number of containers to be sampled depends on the (i) component variability, (ii) confidence level, (iii) degree of precision desired, (iv) past quality history of the supplier, and (v) quantity needed for analysis and reserve samples. For hazardous or highly toxic raw materials, where on-site testing may be impractical, suppliers COA should be obtained, showing that the raw materials conform to specifications. In addition, the identity of these raw materials should be confirmed by examination of containers and labels. The lack of on-site testing for hazardous raw materials should be documented. 

B) Preparation of Sample. Place three of the bottles on a steam heated water bath, retaining one bottle as a reserve sample. Heat until all crysts are completely dissolved and then pour all three bottles into a heated, dry 500 ml Florence flask. Mix well and analyze as follows ... 

---