An audit is a main element in determining the growth and market presence of any organization. The success of an audit is dependent on various factors, that need to be reduced. some of the Audit Checklist for Human Resources and Administration that can be used are described below: 1.0 Personnel Audit Checklist A. Key Personnel … Read more
Due to the growing demand for GMP and regulatory requirements in the pharmaceutical industry, there is a high chance of deviations occurring. These deviations must be documented, and the manufacturing organization recognizes the need for a standard operating procedure (SOP) for handling such deviations. However, even with good compliance practices in place, there may still … Read more
FBD refers to a Fluidized bed dryer that is commonly used in the pharmaceutical industry to reduce the moisture content of pharmaceutical granules. It is the best technique used by the manufacturer to produce a good quality product. However, with time, new advanced techniques are introduced to replace old like; in case of FBD, a … Read more
1.0 Objective: To lay down the procedure for handling filled bottles labeled with improper labels.|2.0 Scope:This procedure is applicable for filled bottles with improper labels in the liquid packing department in Pharmaceuticals3.0 Responsibility:Officer – Production department to implement this standard operating procedure.Manager- Production Department to overall compliance to this operating procedure 4.0 Procedure: 4.1 Types … Read more
Change control is Managing to control a change in a process/procedure/system through proper and scientific justification, review, approval, implementation, follow-up, and closure. EU GMP Annex 15 Guidelines explain “change control” as: “The given statement describes a formal process in which qualified individuals from relevant fields review proposed or actual changes that could potentially affect the … Read more
1.0 Objective: To lay down a procedure for cleaning and operation of inspection unit for empty and filled bottles.2.0 Scope: This Standard operating procedure is applicable for cleaning and operation of the inspection unit for empty and filled bottles in the Liquid department. 3.0 ResponsibilityOperator, officer – Production departmentManager-QA, Production department 4.0 Procedure 4.1 Cleaning4.1.1 … Read more
Track and trace system in pharmaceuticals is a process of determining the current and past history of products through their unique ID, or their properties. It helps the manufacturer to get information about false or copied products in the market. Track system is simply to know about the current and past location of any serialized … Read more
1.0 Objective: To lay down a procedure for Cleaning utensils, SS accessories, and machine change parts.2.0 Scope: This procedure is applicable to cleaning utensils, SS accessories, and machine change parts in the Liquid orals department.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Cleaning Procedure of SS Accessories after every … Read more
Both humidity and relative humidity refer to the amount of water vapour in the air, however, they are not the same. Humidity is the absolute amount of water vapour in the air, whereas relative humidity is the amount of water vapour in the air in comparison to the maximum amount of water vapour the air might … Read more
1.0 Purpose: To lay down the procedure for operation and cleaning of glass, vial/ Syringes crushing machine, and handling of crushed material.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of glass crushing machines and handling of crushed material. 3.0 Responsibility: 3.1 Officer, and Executive – Production Department for implementation of … Read more
The BQS (Blister Quickly Through Servo) Machine is a part of pharmaceutical packaging, where it helps to aggregate unit doses into a blister form, also known as primary packaging. BQS uses continuous motion technology, enabled by flat sealing and flat forming, to achieve precision, power, speed, and position control. BQS machine Change Parts Principle of … Read more
1.0 Objective: To lay down a procedure for microbiological monitoring of compressed air used in manufacturing areas.2.0 Scope: This SOP shall be applicable for a total viable aerobic count of compressed air of “O” Zone and Class 10,000 (liquid manufacturing) area at Manufacturing area. 3.0 Responsibility:Execution: Tr. Executive and above –QC DepartmentChecking: Asst. Manager and … Read more
Hold time is the period during which materials ( Machine Parts) may be held under specified conditions or time and remain within the stipulated requirements. At all phases of production Hold time study on machine change parts to be done on a given frequency to ensure the quality of products. Manufacturers must ensure that the … Read more
1.0 Objective: To lay down a procedure for the Verification of the sugar dissolving tank, manufacturing tank, and holding tank.2.0 Scope: The procedure is applicable to the verification of the sugar dissolving tank, manufacturing tank, and holding tank, installed in the Liquid orals Department. 3.0 ResponsibilityOfficer, and Executive – Production Department for implementation of this … Read more
1.0 Objective: To lay down a procedure for polishing punches and dies.2.0 Scope: This procedure is applicable to the polishing of punches and dies used in the production department.3.0 Responsibility:Officer, and Executive – Production Department for implementation of this procedure.Manager – Production Department for overall compliance with this procedure. 4.0 Procedure:4.1 Select the required brush … Read more
1.0 Objective: To lay down a procedure for change of the aluminum foil during packing.2.0 Scope: This standard operating procedure is applicable to the change of aluminum foil during packing in the production department.3.0 Responsibility: Officer, and Executive – Production Department for implementation of this procedure.Manager – Production Department for overall compliance with this procedure. … Read more