Automatic Cartoning Machine is used for Packing blisters/Strips inside the carton in secondary packing areas in Pharmaceuticals. 1.0 Purpose: The purpose of this standard operating procedure is to lay down the procedure for Operation and Cleaning of Automatic Cartoning Machine (CP-150). 2.0 Scope: This SOP is applicable to the Operation and Cleaning of an Automatic … Read more
Standard Operating Procedure for Operating and Validating a Biosafety Cabinet 1.0 Objective: The purpose of this procedure is to outline how to use and verify the functionality of a Biosafety Cabinet. 2.0 Scope: This procedure covers the usage and internal validation of a Biosafety Cabinet. 3.0 Responsibilities: Microbiologist: Responsible for using, validating, and maintaining the … Read more
Standard Operating Procedure for Operating and Cleaning a Vortex Mixer in the Microbiology Department. I.0 Purpose: The purpose of this SOP is to provide guidelines for the proper operation and cleaning of the Vortex mixer. 2.0 Scope: This procedure applies to the Microbiology section of the Quality Control Department. 3.0 Responsibilities: 3.1 Quality Control Department … Read more
The Antibiotic Zone Reader quickly and accurately helps figure out how strong antibiotics are by measuring the size of the zone where bacteria can’t grow in a Petri dish. 1.0 Objective: The objective of this Standard Operating Procedure is to provide a written procedure for the operation and calibration of the Antibiotic Zone Reader. 2.0 … Read more
Standard Operating Procedure (SOP) for Operation and Calibration of Heating Block 1.0 Objective: The objective of this Standard Operating Procedure is to lay down the procedure for operating and calibrating the Heating Block. 2.0 Scope: This SOP covers the operation and calibration of the Heating Block in the microbiology Lab. 3.0 Responsibility: Microbiologist: Responsible for … Read more
Standard Operating Procedure Operation and Validation of Laminar Air Flow Hood 1.0 Objective: To provide a written procedure for the operation and validation of Laminar Air Flow Hood. 2.0 Scope: This SOP covers the operation and validation (in-house) of Laminar Air Flow Hood. 3.0 Responsibility: Microbiologist: To perform or implementation of this SOPQA Officer/QAM: For … Read more
Standard Operating Procedure for Operating a Centrifuge Machine, This Standard Opеrating Procеdurе (SOP) provides еssеntial procedure and operation of the Centrigue machine. 1.0 Objective: The primary aim of this guideline is to establish the step-by-step process for effectively using the Centrifuge Machine. 2.0 Scope: This Standard Operating Procedure (SOP) outlines the procedure for the proper … Read more
SOP for Colony Counter is an essential step towards maintaining the Functioning and integrity of instruments used in the Pharmaceutical microbiology section. 1.0 Objective: To establish a written procedure for the operation and calibration of the Colony Counter. 2.0 Scope: This SOP covers the process of operating and calibrating the Colony Counter. 3.0 Responsibility: Microbiologist: … Read more
In the challenging field where healthcare and legal complexities clash, a Pharmaceutical Industry Lawyers job appears to be a vital source of guidance. By examining their various responsibilities, we will see how crucial these legal experts are in ensuring that the ethical, regulatory, and business aspects of the pharmaceutical industry are all aligned. Introduction: Pharmaceutical … Read more
1.0 Objective: This document summarizes the procedure for the recruitment of employees within the pharmaceutical industry. 2.0 Scope: This standard operating procedure applies specifically to the Human Resource Department of the pharmaceutical industry. 3.0 Responsibility: The Head of the Human Resource Department and the QA Head are accountable for ensuring compliance with this procedure. 4.0 … Read more
1.0 Objective: This SOP achieves operational qualifications and performance qualifications. 2.0 Aim: This Standard Operating Procedure serves as Preventive Maintenance of the D.M. Plant 3.0 Procedure for Preventive Maintenance of D.M. Plant 3.1 Conduct an annual inspection and replacement of all faulty components.3.2 Apply grease to bolts and nuts to prevent corrosion and facilitate easy … Read more
Standard operating procedure for Handling Chemicals used in Purified Water plants in pharmaceutical industries. 1.0 Objective: This SOP outlines the steps for effectively managing chemicals used in pharmaceuticals for purified water plants.2.0 Scope: This standard procedure applies to the handling of chemicals within the purified water plants at Pharmaceuticals.3.0 Responsibilities: Engineering, Purchase, Warehouse, QC DepartmentsAccountability: … Read more
Standard Operating Procedure on Withdrawal, Storage, Observation & Destruction of Control/Retention Sample in Pharmaceuticals. 1.0 Objective: This SOP applies to the withdrawal, storage, observation, and destruction of control samples from production (OSD & Injectable) and Quality control (R.M. Retention) in the pharmaceutical formulation plant. 2.0 Scope: This Standard Operating Procedure applies to the withdrawal, storage, … Read more
1.0 OBJECTIVE: This procedure outlines the steps for receiving and Handling of Laboratory Samples. 2.0 SCOPE: This standard operating procedure pertains to the receipt and Handling of Laboratory Samples. 3.0 RESPONSIBILITY: The Quality Control Executive/Microbiologist is responsible for the implementation of this SOPThe Assistant Manager QC and/or QA Manager are responsible for Overall compliance with … Read more
OBJECTIVE: To establish a procedure for action to be taken where critical parameters exceed acceptable limits within the purified water system. SCOPE: This Standard Operating Procedure applies to the generation and distribution of purified water systems. RESPONSIBILITY: Officer, Executive – Engineering Department.Head – Engineering Department for overall compliance to this SOP. ACCOUNTABILITY:Head of Engineering PROCEDURE: … Read more
Pharmaceutical incompatibility is defined as any unwanted interaction of two or more drugs that results in a significant change either in the physical, chemical, or therapeutic behavior of drugs. The change can also result in an undesirable product which might affect the safety, efficacy, appearance, and stability of the product. Incompatibility can occur during compounding, … Read more