What’s the checkpoint be at the time of received materials?
plz tell me
thnku
Please find below important aspects to be checked when receiving the raw materials, intermediates etc. required for manufacturing of pharmaceutical finished products and APIs / Intermediates,
Reference: Eudralex, Volume-4 EU GMP, Part 1,Chapter 5: Production
5.3 All incoming materials should be checked to ensure that the consignment corresponds
to the order. Containers should be cleaned where necessary and labelled with the
prescribed data.
5.4 Damage to containers and any other problem which might adversely affect the quality
of a material should be investigated, recorded and reported to the Quality Control
Department.
5.5 Incoming materials and finished products should be physically or administratively
quarantined immediately after receipt or processing, until they have been released for
use or distribution.
5.6 Intermediate and bulk products purchased as such should be handled on receipt as
though they were starting materials.
5.7 All materials and products should be stored under the appropriate conditions established
by the manufacturer and in an orderly fashion to permit batch segregation and stock
rotation.
5.8 Checks on yields, and reconciliation of quantities, should be carried out as necessary to
ensure that there are no discrepancies outside acceptable limits.
Reference:- GOOD MANUFACTURING PRACTICE GUIDE FOR
ACTIVE PHARMACEUTICAL INGREDIENTS- ICH- Q7
7.2 Receipt and Quarantine
7.20 Upon receipt and before acceptance, each container or grouping of containers of
materials should be examined visually for correct labelling (including correlation
between the name used by the supplier and the in-house name, if these are
different), container damage, broken seals and evidence of tampering or
contamination. Materials should be held under quarantine until they have been
sampled, examined or tested as appropriate, and released for use.
7.21 Before incoming materials are mixed with existing stocks (e.g., solvents or stocks in
silos), they should be identified as correct, tested, if appropriate, and released.
Procedures should be available to prevent discharging incoming materials wrongly
into the existing stock.
7.22 If bulk deliveries are made in non-dedicated tankers, there should be the assurance of
no cross-contamination from the tanker. Means of providing this assurance could
include one or more of the following:
certificate of cleaning
testing for trace impurities
audit of the supplier.
7.23 Large storage containers, and their attendant manifolds, filling and discharge lines
should be appropriately identified.
7.24 Each container or grouping of containers (batches) of materials should be assigned
and identified with a distinctive code, batch, or receipt number. This number
should be used in recording the disposition of each batch. A system should be in
place to identify the status of each batch.