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 […]
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
The pharmaceutical industry is a highly regulated sector that requires strict adherence to laws and regulations to ensure the safety and efficacy of its products. One of the key mechanisms for ensuring compliance and mitigating risk is through effective internal audits. Here are some tips to help ensure your internal audits are as effective as
By following these tips and best practices, companies in the pharmaceutical industry can ensure that their cleaning processes are effective and compliant with GMP requirements. By maintaining a clean and well-controlled environment, companies can help prevent contamination and ensure the quality and safety of their products.
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
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
OBJECTIVE : The purpose of this SOP is to lay down the procedure for ( Failure Investigation ) investigation failure of any activity to meet its predetermined specification, limits or acceptance criteria SCOPE : This SOP is applicable to process failures as well as non process failures (e.g. operator related). This SOP is not applicable
OBJECTIVE: The purpose of this SOP is to lay down the procedure for men and material movement. SCOPE: This SOP is applicable for material movement across the different blocks and area and men movement in miscellaneous areas at the manufacturing facility. RESPONSIBILITY: Each individual entering into the area shall be responsible to follow the practice.
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).