1.0   OBJECTIVE: Objective of this report is to provide documented evidence through the verification of  installation, operation &  performance of Tablet Friability Tester to show that the instrument  installed, operated and consistently performed according  to predetermine specifications. 2.0   SCOPE : The scope of this Report is limited to Id No. XYZ 3.0  QUALIFICATION TEAM AND RESPONSIBILITIES: … Continue reading Qualification Report of Tablet Friability Tester (Electro lab) →

OBJECTIVE: Objective of this report is to check and provide documented evidence of its performance as per the predetermined acceptance criteria. Refer working and principle of RMG https://pharmaceuticalupdates.com/2020/04/27/working-and-principle-of-rapid-mixer-granulator-rmg/ 2.   SCOPE: The scope of this report is limited to equipment ID No. XYZ. 3. QUALIFICATION TEAM AND RESPONSIBILITIES: DEPARTMENTNAME AND SIGNATURERESPONSIBILITYQuality Assurance   To prepare performance qualification … Continue reading Performance Qualification of Rapid Mixer Granulator (RMG) with inline Cone Mill →

1.0Objective : To lay down a procedure for Training and Qualification of Quality Control Analyst.2.0Scope : The scope of this document is to provide the procedure for Training and Qualification of Quality Control Analyst.3.0Responsibility :3.1Quality Control Personnel :3.1.1To undergo Training and Qualification.3.2Quality Control Head / Designee :3.2.1To review and monitor the procedure for Training and Qualification of … Continue reading SOP for Analyst Qualification in Quality Control →

ALCOA and CCEA (complete, consistent, Enduring and Available) CCEA (++++ Complete, Consistent, Enduring and Available)

What is Fluid Bed Dryer : FBD is used for drying of different pharmaceutical materials or products and it can easily achieve specific moisture content in granules and powders. FBD is able to remove excess moisture from different materials and its working principle is so precise and focused on drying the materials without changing their … Continue reading Principle and working of Fluidized Bed Dryer (FBD) →

Below given are the details of causes and solutions of defects in tablet Manufacturing. The defects are capping, Lamination, Picking, Sticking, Cracking and Chipping.

OBJECTIVE 1.1 To lay down a procedure for operation of Friabilator, Make: Electro lab 2.0       RESPONSIBILITY 2.1 Technical Assistant / Production Executive / IPQA Executive – To Perform as per SOP. 2.2 Production / IPQA In-charge – To ensure the compliance. 3.0 PROCEDURE 3.1   OPERATION : 3.1.1     Switch ON the mains. 3.1.2    Press the START/STOP … Continue reading Procedure for Operation of Friabilator Make: Electro lab →

What is Audit Trail : An audit trail or  audit log is a security-relevant chronological record, set of records, or destination and source of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, or event.  Audit trail means a secure, computer-generated, time-stamped electronic record that allows … Continue reading Review of Audit Trails in Laboratory Systems →

1.0       OBJECTIVE              1.1         To lay down a procedure for operation of Disintegration test apparatus, Make: Electrolab 2.0       RESPONSIBILITY 2.1        Technical Assistant / Production Executive / IPQA Executive – To perform as per SOP 2.2        Production / QA in-charge  – To ensure the compliance 3.0       PROCEDURE 3.1 Operation      3.1.1 Switch on the mains. 3.1.2 Press … Continue reading Operation of Disintegration test Apparatus Make : Electro lab →

OOS Investigation Flow Chart