Packaging and labeling controls

Packaging and labeling control Holding and distribution Laboratory control Records and reports... 

Subpart E Control of Components and Drug Product Containers and Closures Subpart F Production and Process Controls Subpart G Packaging and Labeling Control Subpart H Holding and Distribution Subpart I Laboratory Controls Subpart J Records and Reports Subpart K Returned and Salvaged Drug Products... 

SUBPART g packaging and labeling control 211.122 Materials examination and usage criteria 211.125 Labeling issuance 211.130 Packaging and labeling operations... 

TABLE 22 Contents of Subpart G of Part 211 of U.S. GMP Regulations Covering Packaging and Labeling Control [7]... 

Correspondences in Canadian GMP Code In the Canadian GMP code [12] issues related to packaging and labeling control are covered in the interpretations of regulations C.02.011 (Manufacturing Control), C.02.017 (Packaging Material Testing),... 

The cGMP regulations include specific packaging and labeling controls, so packaging and labeling requirement, processes, and controls should be included in a QS-based approach to product and process design and development. 

Packaging and labeling control procedures must be adequately written. Poor label control and accountability for other products may have an adverse effect on the firm s ability to ensure that the new drug will always be properly labeled. The label and packaging controls should take into account considerations of past label mix-ups and recalls. 

G Packaging and labeling controls Depyrogenation, sterile packaging, filling and closing, expire dating... 

Manufacturing controls—sample batch records, list of SOPs packaging component control, raw material control, packaging and labeling control, yield accountability and reconciliation, warehousing and distribution... 

Product identification, traceability Packaging and labeling control... 

Handling, storage, packaging, delivery Packaging and labeling control holding, distribution... 

---