SOP on Storage and Hold Time Study for Products

SOP on Storage and Hold time study for Products

Learn About Standard Operating Procedure on Storage and Hold time Study for Products along with their Purpose, Scope, Responsibility, Definition, Procedure, Selection of Test parameters, Sampling Interval/volume, and container, Hold time study at different stages, and Documentation. 1.0 Purpose: 1.1 To lay down Standard Operating Procedure for Storage and Hold Time of Starting Material, Intermediate, and Bulk Products. … Read more

Daily Verification of Weighing balance SOP

Daily Verification of Weighing balance

Learn About Standard Operating Procedures for Daily Verification of Weighing balance along with their, Purpose, Scope, Responsibility, Precautions, Procedure, Operation, and Tolerance limit. 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries.2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in … Read more

Induction Cap Sealer machine SOP

Induction Cap Sealer machine SOP

Learn about the Standard Operating Procedures for the induction cap sealer machine, including their scope, responsibilities, precautions, procedures, and operation. 1.0 Scope: This SOP is applicable to setting and operating an induction cap sealer machine in the tablet department. 2.0 Responsibility: 2.1 Officer production is responsible for the implementation of this SOP2.2 Head production is responsible for ensuring the … Read more

Entry exit Procedure in Pharma SOP

Entry exit Procedure in Pharma SOP

Learn about the Standard operating procedure for “Entry and Exit Procedure in Pharmacautical” along with Purpose, Scope, Responsibility, Instruction, Procedure, Entry procedure for employees, Exit procedure for the employees, and Entry and Exit procedure for visitors. 1.0 Purposes: 1.1 Lay down the standard operating procedure for the entry-exit procedure in pharmaceuticals. 2.0 scope: 2.1 This SOP applies to all personnel, … Read more

Product Waste; Collection and Disposal

1.0 Purpose: To lay down the standard operating procedures for the Collection and Disposal of product waste.2.0 Scope: This scope is applicable to all the product waste generated during the following activities. 3.0 Responsibility:3.1 Officer concerned department is responsible for the Product Waste; Collection and Disposal.3.2 All concerned heads of the department and head of Quality Assurance are … Read more

SOP on Operation, cleaning of Leak Test Apparatus

SOP on Operation, cleaning of Leak Test Apparatus

Learn about Standard operating procedures on Leak Test Apparatus including Purpose, Scope, Responsibility, Procedure, How to perform Leak test for blister and containers and aluminum triplex, limit, Action on Failure of leak test for blister or strips, Frequency, Challenge test, Cleaning and calibration of leak test apparatus. 1.0 Purpose: To let down the standard operating … Read more

SOP for Camera Vision System and Pinhole detector

SOP for Camera Vision System and Pinhole detector

Learn about Standard operating procedures for Camera Vision Systems and Pinhole detector including Aim, Purpose, Responsibility, Precautions, Procedure, Frequency, and Annexures. Aim: Standard operating procedure for camera vision systems in Pharmaceutical Purpose: To lay down the procedure for setting, operation, and in-process check for the camera vision system and pinhole detector. Scope: This standard operating procedure is applicable to carry out … Read more

SOP on Cleaning and Sanitization in Pharmaceutical

SOP on Cleaning and Sanitization in Pharmaceutical

Learn about Standard Operating Procedures on Cleaning and Sanitization in Pharmaceutical including, Aim, Scope, Responsibility, Precautions, Procedure for Different area, Frequency and Annexures. 1.0 Aim: To lay down the SOP for cleaning and sanitization of manufacturing and primary packing area. 2.0 Scope: This SOP is applicable to the entire area in the tablet department at the plant. 3.0 Responsibility officer:3.1 Production is responsible for … Read more

SOP on the Training of Personnel in Pharmaceutical

Training of personnel

1.0 Purpose: The purpose of this SOP is to lay down the procedure for effective training of personnel working at a manufacturing site. In order to ensure that all employee receives appropriate training which would enhance their knowledge, experience, skill, ability, and behavior to execute their appropriate duties and responsibilities in such a manner, to provide Assurance that the … Read more

SOP on Solid flow Monitor Test in Fluid bed dryer

SOP on Solid flow Monitor Test in Fluid bed dryer

Learn about Standard Operating procedures on Solid flow Monitor Test to check the integrity of bags including Purpose, Scope, Responsibility, Procedure, and Precautions. Importance of SFM test: A solid flow monitoring test is used in pharmaceuticals to determine the integrity of the fluid bad drier bags. SFM test senses the flow of powder, and FBD … Read more

SOP for Calibration of Weighing Balance (Trolley balance)

SOP for Calibration of Weighing Balance

Learn about Standard operating procedures for calibration of weighing balance, including Aim, Purpose, Scope, Responsibility, precaution, Operation, and cleaning. 1.0 Aim: The SOP for calibration of weighing balance (Trolley Balance) is applicable for all departments at the Production site.2.0 Purpose: The purpose of this sop is to calibrate of weighing the balance of the bin lifting trolley.3.0 Scope: This sop is applicable … Read more

SOP for Coding and Calibration of Standard Weight

Calibration of Standard weight

Standard Operating Procedure for Coding and Calibration of Standard Weight, Scope, Responsibility, Precautions, Frequency, Procedure, and Yearly Calibration of Analytical Weight and Standard Weight. 1.0 Scope: The SOP is applicable for the Coding and Calibration of Standard Weight including analytical balance in the various departments at the plant. 2.0 Responsibility: 3.0 Precautions:3.1 Check the validity of the calibration … Read more

SOP for Acceptable Quality Level with Chart Parameters

SOP for Acceptable Quality Level in Pharma

Standard Operating Procedure for Acceptable Quality Level (AQL) includes; Purpose, Scope, Responsibility, Precautions, Procedure, Classification of Defects for AQL, and AQL Charts. 1.0 Purpose: To lay down the standard procedure for an acceptable quality level for semi-finished tablets to evaluate physical attributes before packing. 2.0 Scope: This sop is applicable to all tablet products manufactured at the … Read more