Procedure for Destruction Microbial waste by Autoclaving

by
SOP for Destruction Microbial waste

Learn About Standard operating procedures for the Destruction of Microbial waste by Autoclaving methods along with their Objective, Scope, Responsibility, and procedure. 1.0 Objective: 1.1 To lay down the procedure of the Destruction of microbial waste by autoclaving.2.0 Scope: 2.1 This SOP applies to carry out the procedure of Destruction of microbial wastes by autoclaving in a microbiology laboratory 3.0 Responsibility: 3.1 … Read more

Contamination and Cross-contamination in Manufacturing

by
Contamination and Cross-contamination illustration

Contamination and cross-contamination are terminologies used in the pharmaceutical industry when products undesirably come into contact with or mix with other products or their parts. Contamination can occur in starting materials or products due to contact with other related products. The risk of accidental contamination may arise from the uncontrolled release of dust, gases, particles, … Read more

MACO and NOEL Calculation for cleaning Validation

by
MACO and NOEL Calculation

MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. NOEL is used to determine MACO during cleaning validation. NOEL Calculation: NEOL is calculated by using LD50 and average. Adult dose. LD50 is a lethal dose (it may vary), considered an adult’s … Read more

Difference between Static and Dynamic Pass box

by
Difference between Static and Dynamic Pass box

Pass boxes are cleanroom systems used to transfer materials from one area to another cleaned area through a controlled environment. Pass boxes help control contamination and cross-contamination by passing particular matter present on the surface of materials that are to be transferred. These materials automatically pass through the filter present on the pass box during … Read more

Good Documentation Practice (GDP) in Pharmaceuticals

by
Good Documentation Practice

Documentation forms the base of any company’s Quality Management System and serves as an essential GMP requirement. Anyone handling GMP documents and documentation systems must understand the regulatory requirements. Requirement of Good Documentation Practice? Good Documentation Practice is essential for proof of invention, company operations, technology transfer, regulatory requirements, and liability protections. The Documentation System … Read more

GxP in Pharmaceuticals industries (FDA guidelines)

by
GxP in pharmaceutical

GxP in pharmaceuticals is a set of Good Practices; it ensures the quality and effectiveness of products for drugs, food, medical equipment, and other life-serving products as per regulatory standards. Meaning of GxP in Pharmaceuticals: GxP is part of Good practice because it’s related to the manufacturing of life-saving products. GxP helped in controlling the … Read more

SOP on Cleaning Procedure for Sterility Failure investigation

by
SOP on Sterility Failure

Learn About Standard Operating Procedure for Sterile failure investigation within sterile testing Areas including their, Aim, Scope, Responsibility, Procedure, and Definitions. 1.0 AIM: To lay down the cleaning procedure for the Sterility failure investigation.2.0 SCOPE: This SOP applies to carry out the cleaning procedure for the Sterility failure investigation.3.0 RESPONSIBILITY: Executive – Provide training for Cleaning procedure for the Sterility testing area … Read more

SOP on Operation of Laminar airflow in a Micro laboratory

by
SOP Laminar airflow

Learn About Standard operating procedure on Laminar airflow in a Micro laboratory including their, Aim, Scope, Responsibility, distribution, Procedure, and Annexures. 1.0 AIM: To lay down the procedure of Operation of Laminar airflow in the microbiology laboratory.2.0 SCOPE: This SOP applies to carry out the procedure Operation of Laminar airflow in the microbiology laboratory at a pharmaceutical plant. 3.0 RESPONSIBILITY:3.1 Executive … Read more

Procedure for Microbial Incubator operation & Calibration

by
Microbial Incubator

Learn About Standard Operating Procedure for Microbial Incubator operation and their Calibration along with Objective, Scope, Responsibility, Procedure, Frequency, and Tolerance Limits 1.0 Objective: To get reliable and consistent results, we must ensure the procedure and maintenance of the Microbial Incubator, especially for temperature maintenance for Microbial growth. 2.0 Scope: This procedure is applicable to … Read more

Procedure for Planned Internal Quality Audits in Pharma

by
Procedure for Planned Internal Quality Audits in Pharma

Discover the effective process for conducting planned internal quality audits within the pharmaceutical industry. Learn how to optimize quality assurance practices while ensuring compliance with regulatory standards. Gain insights into enhancing pharmaceutical audit procedures and achieving operational excellence. 1.0 PURPOSE: 1.1 The purpose of this procedure is to implement a system for planned internal quality audits … Read more

Difference Between Validation, Calibration, and Qualification in Pharma

by
Difference Between Validation, Calibration, and Qualification

There is often confusion surrounding the terms validation, calibration, and qualification within the pharmaceutical industry. Let’s explore their differences with explanatory examples. Difference among Validation, Calibration, and Qualification 1. Qualification: Qualification is the process of planning, conducting, and documenting test results performed on equipment to confirm its operational capability. It demonstrates that the equipment will … Read more

SOP on Storage and Movement of unlubricated granules / Transfer

by
SOP on Movement of unlubricated

Learn about Standard Operating procedures for Storage and Movement of unlubricated granules / Transfer including their Purpose, Scope, procedure for Storage of Unlubricated / Graded Granules, transfer of Unlubricated Granules to Blender Room, Precautions, and Annexures. 1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for storage and movement of unlubricated granules and their transfer to … Read more

SOP on Storage and labeling of Raw and Packing Materials

by
SOP on Storage and labeling of Raw and Packing Materials

Learn About Standard Operating Procedures for Storage and labeling of Raw and Packing materials including their, Purpose, Scope, Responsibility, Procedure, Precautions, and Records. 1.0 Purpose: 1.1 The purpose of this SOP is to implement system storage and labeling of Raw and Packing materials in raw material stores.2.0 Scope: 2.1 This SOP is applicable to all raw materials; packaging … Read more

SOP on Rapid Mixture Granulator cleaning and procedure

by
SOP for Rapid Mixture Granulator cleaning and procedure

Learn about the Standard Operating procedure on RMG including their, Purpose, Scope, Responsibility, Checkpoints, procedure, cleaning, discharging, and Frequency. 1.0 Purpose: To lay down SOP on Rapid Mixture Granulator for Operation and Cleaning.2.0 Scope: This SOP applies to RMG operation and cleaning In pharmaceuticals.3.0 Responsibility: 3.1 Operator, Officer Production is responsible for the implementation of this SOP.3.2 Head Production is responsible for ensuring compliance with this SOP … Read more

SOP on Vibro Sifter operation and Cleaning

by
Vibro Sifter SOP

A vibro sifter is used in pharmaceuticals to crush the solid mass of granules and create the desired size of granules using sieves. Let’s understand the cleaning and operation procedures of the vibro sifter. 1.0 Objective: 1.1 To lay down the procedure for Vibro Sifter operation and Cleaning2.0 Aim: This procedure is applied to Vibro … Read more

Vernier Caliper measurement and operation in Pharma

by
vernier caliper

Vernier caliper is used widely in pharmaceutical and other industries for Accurate Measurement of any products and part of the equipment is essential to know the actual dimension. So to measure the dimension first you have to know about, the vernier caliper Definition, procedure, parts, operation, cleaning, error solutions, and purpose. Vernier Caliper Definition: The Dial … Read more