Understand ICH Q7 S7

What is meant by ‘completely distributed’ in [ICH Q7, 6.13], which states that ‘records should be retained for at least 3 years For APIs with a retest date, [ICH Q7, 6.13] states that after the batch is completely distributed’? 

For APIs with a retest date, [ICH Q7, 6.13] states that records related to production, control and distribution should be retained for at least 3 years after the API batch is ‘completely distributed’, which is understood as the complete distribution of the entire batch of the API by the API manufacturer to the next party in the supply chain. In the case of APIs handled by agents, brokers, traders, distributors, repackers, and relabellers [ICH Q7, 17], ‘completely distributed’ refers to distribution of the received quantity of the batch of API. The intent of ICH Q7 is to retain records for the period of time that the API could be on the market in order to investigate any problems and/or product complaints. Based on accepted industry practice at the time ICH Q7 was written, it was not anticipated that a manufacturer would set a retest date longer than 3 years. However, the use of ‘at least three years’ in this section of ICH Q7 covers longer record retention periods, which is in alignment with the basic GMP principle and/or regional requirements that records be retained for the entire period the material is available on the market. It is good industry practice to consider retaining records for the period of time the drug product(s) in which the API was used may be available on the market. 

Does a batch numbering system need to be sequential? 

No, [ICH Q7, 6.51] says only that batch production records should have a unique batch or ID number. ds? [ICH Q7, 2.3] does not specify who is responsible for the issuance of batch production records [ICH Q7, 6.5] as long as the issuance process is described in writing and approved by the quality unit [ICH Q7, 2.21]. 

Does the phrase ‘grouping of containers’ have the same meaning in [ICH Q7, 7.20 and 7.24]? 

The phrase ‘grouping of containers’ should be read in the context of each sentence. A grouping of containers refers to multiple containers physically secured by the supplier (e.g., shrink-wrapped pallet, etc.) usually intended for ease of shipment and reconciliation. [ICH Q7 7.20] is referring to incoming visual examination of materials before acceptance into the facility under quarantine. The phrase in [ICH Q7, 7.24], ‘grouping of containers (batches)’ contains an additional word ‘batches’ because this section is addressing the need to establish batch traceability for the incoming material.