Tableting tools i.e., Punches and dies are essential tools to shape any granules into a solid dosage form by applying compaction force in a compression machine. Any shape be it round, capsule, animal shape, bullet shape or any special shape can be obtained with the help of the standard tooling. In the ...

Hold Time studies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not degrade significantly during the hold time at a required temperature and Relative Humidity. When appropriate, time limits for the completion of each ...

OBJECTIVE: To establish a standard procedure for handling of gas cylinder. SCOPE This SOP is applicable for (Company Name). RESPONSIBILITY 3.1 Operator shall be responsible to follow the procedure strictly. 3.2 Supervisor shall be responsible to ensure that the SOP is followed properly. ACCOUNTABILITY Head ...

1️⃣ Hemgenix (etranacogene dezaparvovec): Gene therapy that introduces a functional gene into the body. This enables the production of functional factor IX (a protein necessary for normal blood clotting), enhancing the body’s natural clotting ability. 2️⃣ Skysona (elivaldogene autotemcel): ...

In the realm of pharmaceutical manufacturing, ensuring product quality, efficacy, and safety is paramount. One crucial aspect contributing to these factors is the concept of hold time studies. Hold time refers to the duration that materials, intermediates, or products are kept in a controlled environment ...

OBJECTIVE To establish and define methods to be used in the care of facilities to ensure compliance with GMP. SCOPE This SOP shall be applicable for all Departments. ASSOCIATED DOCUMENTS Not applicable. RESPONSIBILITY/ACCOUNTABILITY 4.1 All employees shall be responsible for the care of the facilities. 4.2 Head ...

1.0 OBJECTIVE To provide a procedure to evaluate a potential new source or to monitor ongoing quality on a routine basis for existing vendors. 2.0 SCOPE This SOP shall be applicable to all vendors manufacturing raw & packaging materials supply to the BPL. 3.0 ASSOCIATED DOCUMENTS Not applicable. 4.0 ...

1.0 Objective To establish a procedure for handling socks worn in Production area. 2.0 Scope This SOP shall be applicable for Production, Engineering, Quality Assurance and Quality Control Department. 3.0 Associated Documents 3.1 SOP: Laundering Attires of Different Areas 3.2 SOP: Dress Requirement and ...

1.0 Objective To provide guidelines for the transfer of analytical methods for testing of raw materials and finished products to site laboratories where the routine testing shall be carried out including the training of the concerned analyst and proper documentation. 2.0 Scope This procedure is applicable ...

OBJECTIVE: This Standard Operating Procedure is to describe that room can not randomly selected and directly used without verification. It is essential to ensure the suitability of room for a specific activity against requirement. Hence it is to be qualified before use. SCOPE: This procedure is applicable ...