SOP on Disposal in Tablet Department

1.0 Objective: To lay down a procedure for disposal in the tablet department.2.0 Scope: This procedure is applicable to disposal in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure Disposal in Tablet: 4.1 All used polythene bags (used for granules, raw materials, compressed and coated tablets, etc.) are collected in … Read more

Powders; Types, Advantages, and Disadvantages

pharmaceutical powder and aids

Pharmaceutical powders are solid dosage forms of medicament in which one or more drugs are dispensed in a finely divided state with or without excipients. they are generally available in crystalline or amorphous form. It is used internally and externally. Types of Powders A) Divided Powder: It is a unit dosage form that is normally … Read more

SOP On Movement of Material from One Stage to Another

1.0 Objective: To lay down a procedure for the movement of material from one stage to another.2.0 Scope: This procedure is applicable for the movement of material from one stage to another stage during various processes in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 Store to … Read more

Various Types of HPLC Columns

Cutaway illustration of various types of HPLC columns packed with porous particles, with an HPLC system behind them

The High-Performance Liquid Chromatography (HPLC) column is the heart of the system. It holds the stationary phase that separates sample components. This article explains the various types of HPLC columns: guard, derivatizing, micro (capillary), analytical and preparatory columns, and what each one does in the analysis. This article covers the various types of HPLC columns … Read more

SOP on Operation of Filter Press

Blue SOP file titled “SOP on Operation of Filter Press” placed on a stainless steel table in a pharmaceutical production area, with a stainless steel filter press machine and pipelines visible in the background.

1.0 Objective: To lay down the procedure for operation of Filter Press. 2.0 Scope: This procedure is applicable for the operation of the Filter Press in the liquid oral department. 3.0 Responsibility:Production Officer, Production Executive. 4.0 Procedure:4.1 Assembling: 4.1.1 The filter press consists of 9 sets of filter plates, mesh, and non-woven filter pads alternating … Read more

Methyl Orange indicator Preparation | How to make w/v Methyl Orange

Aim: Methyl Orange Indicator Preparation | How to make w/v methyl orange Requirements: Glasswares: Burette, burette stand, conical flask, volumetric pipette, beaker, measuring flask, funnel, glass rod, wash bottle, storage container, etc. Chemicals: Methyl orange, Ethanol 20 ml, and Distilled water. Procedure for Methyl Orange Indicator preparation Related Post: Preparation and Standardization of 0.1 N HCl

SOP on cleaning of new equipment/ machinery

Six-step infographic for the SOP on cleaning of new equipment/machinery, from vacuum de-dusting to a QA CLEANED label

This SOP on cleaning of new equipment/machinery is a procedure that describes how the production department cleans new equipment, machinery, in-process product containers and accessories on receipt. De-dust with a vacuum cleaner, rub with maize starch, clean with purified water, dry with a lint-free cloth, wipe with 70 % IPA, then apply a ‘CLEANED’ label … Read more

SOP on Change Control / FDA Change Control

1.0 OBJECTIVE: 1.1 To define SOP on Change Control to be made in the authorized documents, validated methods, process, procedures, facilities, and equipment. 2.0 RESPONSIBILITY2.1 Assistant / Chemist / Executive – To initiate the Change Control Form.2.2 Respective Department Head – To evaluate and justify the required change.2.3 Other Departments Heads – To review and … Read more

SOP on Handling Products During a Power Failure

Technician with clipboard checks a wall panel beside a tablet press, for an SOP on handling products during a power failure

The SOP on handling products during a power failure tells staff to switch off the machine main, protect or unload in-process material, and check temperature, humidity and air differential pressure after power resumes. Record the conditions and the activity in the BMR/BPR. It covers granulation, compression, coating, inspection and packing areas. 1.0 Objective To lay … Read more

Fundamentals of Validation SOP

Purpose: The goal of establishing Fundamentals of Validation SOPs is to help the parent business, affiliates, and contract manufacturers understand and maintain the validation program in order to meet GMP regulations. Responsibility: The quality assurance manager is responsible for developing and maintaining the validation program. Compliance with SOPs is the responsibility of departmental managers and contrac­tors. … Read more