SOP on Good Documentation Practices

SOP on Good Documentation Practice

Learn in Detail about the Procedure (SOP) of Good Documentation Practices | Good Documentation Practices FDA Guidance | 5 Principles of Good Documentation Practices. 1.0 AIM: To lay down procedure on Good Documentation Practice in Pharmaceuticals areas. 2.0 PURPOSE: The purpose of this Standard Operating Procedure is to define the entry in the document records … Read more

Pharma Guideline on How to Prepare SOP (SOP of SOP) with Formats

How to Prepare SOP (SOP of SOP) with Formats

Learn About SOP of SOP (How to Write SOP by implementing Different Fonts, Size, Title, Logo, Stamps, Formats, BMR/ BPR, Spec/STP, protocols, Worksheets, Reports, and Logbooks, and Annexures as per the Pharmaceutical Guidelines). 1.0 OBJECTIVE: 1.1 To lay down the procedure for the preparation of SOP (SOP on SOP), Format, Numbering, Review, Approval, Implementation, Distribution, … Read more

SOP on Transfer and Receipt of bulk (ARM) from Warehouse to Production area

SOP on Transfer & Receipt of bulk (ARM) from Warehouse to Production area

Learn About SOP on Transfer and Receipt of bulk (Active Raw Materials) from the Warehouse to the Production area. 1.0 Purpose:   To describe the procedure for transfer and receipt of bulk (Active Raw material) from the warehouse to the production area (Vaccine Formulation). 2.0 Applicable:   This Standard Operating Procedure applies to the transfer … Read more

Fluidized bed Dryer Bag SOP (FBD)

fluidized bed drier

Learn about Standard Operating Procedure on FBD Bag including their, Purpose, Scope, responsibility, Procedure for Indenting, Receiving, cleaning, storage, Issuance and Coding of FBD Bag. 1.0 Purpose: To lay down Standard Operating Procedure for Indenting, Receiving, Issuance, Coding, Usage, Cleaning, and Destruction of Fluidized-bed Dryer Bag.2.0 Scope: This SOP applies to all the FBD Bags used in the Tablet … Read more

SOP for estimation of Nickel (IS 12122 -1987)

Standard working procedure for estimation of Nickel / Standard Working procedure for Nikel estimation by using AAS Methods. Principle: The Nickel content in the sample is determined by aspirating the sample into the flame of an Atomic Absorption Spectrophotometer after pre-concentration. Measured the Absorbance at 232 nm using a Nickel Hollow Cathode Lamp. Limit of … Read more

SOP for Estimation of Sodium (Part 45)

Standard operating/ Working procedure for Estimation of Sodium, Physical and chemical methods of sampling and test for water and wastewater: Part 45 Sodium Principle: When a sodium-containing solution is put into a flame, the brightness of the light passing through it will decrease depending on how much sodium is in the solution. A special lamp … Read more

SOP for estimation of BORON

Standard Operating procedure for estimation of BORON in Pharmaceutical and scientific labs. Principle: When Azomethine-H, which comes from condensation of H Acid (8-amino-naptha-1-ol-3.6-disulphonic Acid) and Salicyladehyde, reacts with borate in a watery solution with a pH higher than 6, it a yellow complex that we can measure using a spectrophotometer. To understand the yellow complex … Read more

SOP on Reference Standards and impurities

SOP on Reference Standards and impurities

Standard Operating Procedure on Procurement, Storage, Usage, and Destruction of Reference Standards and Impurities. In this SOP you will learn about the following: Related SOP: SOP on Withdrawal, Storage, Observation & Destruction of Control Sample 1.0 Objective: 1.1 To lay down a procedure for the Procurement, Storage, Usage, and Destruction of Reference Standards and impurities.2.0 … Read more

SOP on Working Standards- Preparation, Qualification, Usage, Storage, and Destruction

SOP on Working Standards

Standard operating procedure on Preparation, Qualification, Usage, Storage, and Destruction of Working Standards in Pharmaceutical Labs. Working standard SOP will cover the following points: 1.0 Objective: 1.1 To lay down a procedure for the Preparation, Qualification, Usage, Storage, and Destruction of Working Standards.2.0 Scope: 2.1. This procedure applies to the Preparation, Qualification, Usage, Storage, and … Read more

SOP on Operation of Fume Hood

SOP on Operation of Fume Hood

Standard operating procedure on Operation of Fume Hood and the Precaution to be taken before its operation. 1.0 Purpose: For proper handling of the instrument and to save the environment of the QC laboratory from hazards and corrosive chemicals in the laboratory. 2.0 Scope: This SOP is applicable to all hazards, volatile and corrosive chemicals … Read more

SOP on Procurement, Usage, and Storage of Primary Standards

SOP on Procurement, Usage, and Storage of Primary Standards

Standard Operating procedure on Procurement, Usage, and Storage of Primary Standards in Pharmaceutical Quality control Department. 1.0 Objective: 1.1 To lay down a procedure for Procurement, usage, and storage of primary standards 2.0 Scope: 2.1 This procedure is applicable for the Procurement, usage, and storage of primary standards being used in the Quality Control Department … Read more

SOP on intimation to QC Department for Retesting of Raw Materials

SOP on intimation to QC Department for Retesting of Raw Materials

Standard operating procedure on intimation to QC Department for Retesting of Raw Materials 1.0 Objective: To lay down the procedure for intimation to the QC Department for Retesting of Raw Materials2.0 Aim: This procedure applies to the Warehouse department in the pharmaceutical industry.3.0 Responsibility: 3.1 Raw material warehouse personnel to follow the procedure.3.2 Q.C. officer … Read more

SOP for Operation and Calibration of Flame Photometer

SOP for Operation and Calibration of Flame Photometer

Standard operating procedure for Operation and Calibration of Flame Photometer 1.0 Objective: To lay down the procedure for the operation and calibration of the Flame photometer.2.0 Scope: This procedure applies to Flame Photometer instrument installed in the Quality Control Department in Pharmaceutical.3.0 Responsibility: Officer/ Execution responsible for the implementation of this procedure.QC Asst. Manager/ Manager … Read more

SOP for Operation of Digital Griffin Flask Shaker

Digital Griffin Flask Shaker

Standard Operating Procedure for Operation of Digital Griffin Flask Shaker 1.0 Objective: To provide a procedure for operating the digital Griffin flask shaker. 2.0 Scope: The procedure shall be applied when operating the digital Griffin flask shaker in the Q.C Laboratory. 3.0 Responsibility: QC Executive and any personnel using the equipment to follow the outlined … Read more

SOP on Temperature Mapping in RM, PM, FG and Control Sample Area

Standard Operating procedure on SOP on Temperature Mapping in RM, PM, FG, and Control sample Area 1.0 Objective: To Lay down the Procedure for Temperature Mapping in PM, RM, FG, and Control Sample area (Storage Area).2.0 Scope: 2.1 This SOP shall apply to all storage areas in Pharmaceutical industries.3.0 Reference: In –House 4.0 Responsibility:4.1 RM, … Read more