Quality Assurance

Critical quality attributes (CQAs) in the compression stage of tablet manufacturing

Quality Assurance

The compression stage is a critical step in the tablet manufacturing process. During this stage, the powders or granules that have been blended and mixed in the previous stages are compressed into tablets using a tablet press machine. The compression process involves applying high pressure to the powder mixture, which forms the tablet and gives …

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Hold Time Study Report for Dirty Equipment in the Injection Ampoule Section

Quality Assurance

A hold time study report is an essential part of the quality control process that determines the maximum time for which a product can be held or stored under specified conditions. In the case of dirty equipment in the injection ampoule section, this study is critical for ensuring that the equipment does not introduce contamination …

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SOP For Handling of Reprocessing, Reworking and Recovery

Quality Assurance

OBJECTIVE: The purpose of this SOP is to lay down a procedure for reprocessing, reworking and recovery of the drug products. SCOPE:  This SOP is applicable for handling of reprocessing, reworking and recovery of the drug products, at different stages of manufacturing, at the manufacturing facility.     RESPONSIBILITY: Authorized Designee of Quality Assurance shall …

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SOP for Handling of Artwork

Quality Assurance

OBJECTIVE: The objective of this SOP is to lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork. SCOPE:  This SOP is applicable for preparation, approval, distribution, revision, retrieval and destruction of artwork at the manufacturing facility. RESPONSIBILITY: Marketing: Responsible for Color and Design Production Department: Responsible for mentioning size as …

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SOP For Acceptance Quality Level

Quality Assurance

1.0  OBJECTIVE    To lay down the procedure for the visual inspection and statistical evaluation of  a batch ( Acceptance Quality Level). SCOPE This procedure is applicable for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation,   coating and packing in the company (XXX Name of the company). …

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