Chemical SOP
Microbiology SOP
Warehouse SOP
Manufacturing SOP
Information technology SOP
Post Views: 309,000
Risk Assessment for Electricity Failure in Pharma
Documents

Risk Assessment for Electricity Failure in Pharma

Post Views: 3 Introduction: Electricity is a critical utility in pharmaceutical manufacturing facilities, research laboratories, and quality control environments. It powers essential systems, including production

Risk Assessment for using Expired Filter Bags
Documents

Risk Assessment of using Expired Filter Bags

Post Views: 12 Introduction: Filter bags are critical components used in various manufacturing processes to remove particulate matter, ensure product purity, and maintain process sterility

Risk Assessment for Guidelines not followed
Documents

Risk Assessment for Guidelines not followed

Post Views: 8 Pharmaceutical guidelines are structured recommendations and requirements established to ensure that medicinal products are consistently produced, controlled, and distributed to the highest

Risk Assessment
Quality Risk Assessment

Risk Assessment for Not Hiring IT Personnel

Post Views: 28 Risk Assessment for Not Hiring IT Personnel in pharmaceutical industry for ensuring compliance, data integrity, operational efficiency, and patient safety. This risk

Risk Assessment
Quality Risk Assessment

Risk Assessment for Employees not following Hierarchy

Post Views: 19 This document presents a Risk Assessment for Employees Not Following Hierarchy in a small pharmaceutical company.In smaller organizations, clear reporting lines and

Risk Assessment of QMS Not Effective
Documents

Risk Assessment of QMS Not Effective

Post Views: 33 Risk Assessment of QMS Not Effective, an effective Quality Management System (QMS) forms the foundation of consistent product quality, regulatory compliance, and

Risk Assessment of API Calculation Not Verified
Documents

Risk Assessment of API Calculation Not Verified

Post Views: 25 In pharmaceutical manufacturing, the calculation of Active Pharmaceutical Ingredient (API) quantities plays a critical role in ensuring that each batch meets the

Risk Assessment for Persons not trained in ERP
Documents

Risk Assessment for Persons not trained in ERP

Post Views: 13 Enterprise Resource Planning (ERP) is an integrated software solution that enables organizations to manage and automate core business processes within a unified

Documents

Risk Assessment for Media Fill not Performed

Post Views: 21 1. What is Media Fill? Media fill (Process Simulation): Regulatory Expectation: Frequency: 2. Hazard Identification Hazard: Failure to perform or complete required

Risk Assessment for AQL not performed
Documents

Risk Assessment for AQL not performed

Post Views: 40 Introduction: The Acceptable Quality Level (AQL) inspection is a critical component of the quality assurance process that determines whether a batch of

Poster

Post Views: 70

Media Fill
Documents

Risk Assessment for Media Fill

Post Views: 5 Introduction: Media fill is a simulation of the actual aseptic manufacturing process, where instead of the drug product, a nutrient-rich microbiological growth

Quality Risk Assessment

RISK ASSESSMENT FOR QC INSTRUMENTS

Post Views: 530 A Risk Assessment for QC instruments in the pharmaceutical industry is critical to ensure accurate, reliable, and compliant data. The purpose of

Deviations in Pharma
DEVIATIONS IN PHARMA

DEVIATIONS IN PHARMA

Post Views: 485 In the pharmaceutical industry, “deviation” refers to any departure from approved processes, procedures, specifications, or expected outcomes. These deviations can occur during

Change Control in Pharma

CHANGE CONTROL IN PHARMA

Post Views: 714 Change Control in the pharmaceutical industry is a critical part of Quality Management System (QMS). It ensures that all changes to a

Artwork in Pharma
ARTWORKS IN PHARMA

ARTWORKS IN PHARMA

Post Views: 414 Pharmaceutical Artwork refers to the design and layout of packaging, labels, and informational leaflets for medicines. It plays a crucial role in

Line Clearance in Pharma
Line Clearance

LINE CLEARANCE IN PHARMA

Post Views: 1,034 Line clearance in the pharmaceutical industry is a critical process that ensures a production line is free from contaminants, previous product residues,

Regulatory Affairs
Regulatory Affairs

REGULATORY AFFAIRS SOP IN PHARMA

Post Views: 762 Regulatory affairs (RA) in pharma is a critical function that ensures pharmaceutical products meet legal and safety standards before they reach the

Supply & Chain Management
SUPPLY CHAIN MANAGEMENT

SUPPLY CHAIN MANAGEMENT SOP IN PHARMA

Post Views: 483 Supply chain management (SCM) in the pharmaceutical industry is a complex and highly regulated process that ensures the efficient flow of medicines

PHARMA POLICIES

PHARMA POLICIES

Post Views: 1,088 Pharmaceutical policies in a manufacturing plant focus on ensuring product quality, safety, compliance, and efficiency. These policies are governed by regulatory agencies

SELF-INSPECTION

SELF-INSPECTION

Post Views: 988 Self-inspection in the pharmaceutical industry is a critical aspect of Good Manufacturing Practices (GMP) compliance. It involves an internal audit conducted by

ENVIRONMENT MONITORING SYSTEM

ENVIRONMENT MONITORING SYSTEM (EMS)

Post Views: 819 An Environment Monitoring System (EMS) in pharmaceuticals ensures that critical areas comply with the regulatory requirements for cleanliness, temperature, humidity, pressure, and

Formulation, Research and Development

FORMULATIONS, RESEARCH AND DEVELOPMENT

Post Views: 532 Pharmaceutical formulation and development involve transforming active pharmaceutical ingredients (API’s) into safe, effective, and patient-friendly medications. This process encompasses several key stages:

AHU Qualification

AHU QUALIFICATION

Post Views: 2,310 An Air Handling Unit (AHU) is a central component of HVAC (Heating, Ventilation, and Air Conditioning) systems. Its primary function is to

Hormones in Pharma
HORMONES

HORMONES IN PHARMA

Post Views: 1,784 A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out

HAZARD IDENTIFICATION AND RISK ASSESSMENT
Safety

HAZARD IDENTIFICATION AND RISK ASSESSMENT (HIRA)

Post Views: 3,120 HIRA (Hazard Identification and Risk Assessment) is a structured method for detecting and evaluating hazards in process facilities/systems. HIRA detects potential risks that

PREVENTIVE MAINTENANCE

PREVENTIVE MAINTENANCE IN PHARMA

Post Views: 5,254 Preventive Maintenance is performed when the equipment is in working condition and satisfactorily produces a desired output within the capacity. Preventive Maintenance in

USER REQUIREMENT SPECIFICATION FOR OPHTHALMIC

USER REQUIREMENT SPECIFICATION FOR OPHTHALMIC

Post Views: 2,567 A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the

User Requirement Specification for Ampoules
URS FOR AMPOULES

USER REQUIREMENT SPECIFICATION FOR AMPOULES

Post Views: 2,212 The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of

Oncology in Pharma
ONCOLOGY QUALIFICATION

ONCOLOGY IN PHARMA

Post Views: 1,612 Oncology in the pharma industry is the development and manufacturing of cancer treatments. The term “Oncology” comes from the words “Onco” which means bulk,

User Powder Injection for Dry Powder Injection
User Requirement Specification

USER REQUIREMENT SPECIFICATION FOR DPI

Post Views: 2,532 A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such

URS FOR OINTMENTS
URS FOR OINTMENTS

USER REQUIREMENT SPECIFICATION FOR OINTMENTS

Post Views: 2,955 A User Requirement Specification Ointments is a document that defines the procurement requirements for equipment. It’s usually written early in the validation process,

Documents

PLACEBO

Post Views: 2,317 A placebo is a “physiologically inert substance or sham intervention (psychological, physical or mechanical) which produces beneficial effects independent of any direct therapeutic effects”. The

OCCUPATIONAL EXPOSURE LEVEL (OEL) IN PHARMA

OCCUPATIONAL EXPOSURE LEVEL (OEL) IN PHARMA

Post Views: 4,428 In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for

Lyophilizer Qualification in Pharma
Qualification

LYOPHILIZER QUALIFICATION IN PHARMA

Post Views: 4,469 Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a

Analytical Method Validation
ANALYTICAL METHOD VALIDATION

ANALYTICAL METHOD VALIDATION IN PHARMA

Post Views: 7,488 Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various

Product Recall in Pharma
PRODUCT RECALL

PRODUCT RECALL IN PHARMA

Post Views: 2,894 🚨 PRODUCT RECALL IN PHARMA A product recall is a critical GMP process used to remove a defective, potentially harmful, or non-compliant

microbiology sop in pharma

MICROBIOLOGY SOP IN PHARMA

Post Views: 23,122 Microbiology SOP in Pharma plays important role in pharmaceuticals. Microbiology is the study of microscopic living organisms, such as bacteria and fungi.

Documents

PHARMA BOOKS

Post Views: 4,145

Facility Qualification in Pharma
Documents

FACILITY QUALIFICATION

Post Views: 8,204 🏭 FACILITY QUALIFICATION IN PHARMA Facility qualification is a systematic process of verifying and documenting that the design, construction, and operation of

Packing Material STP in Pharma
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PACKING MATERIALS IN PHARMA

Post Views: 3,866 📦 Packing Materials in Pharmaceuticals 🎯 Purpose Packing materials protect drug products from: They also: 🧭 Classification of Packing Materials 1️⃣ Primary

TRANSPORT VALIDATION IN PHARMA
Documents

TRANSPORT VALIDATION IN PHARMA

Post Views: 3,689 Transport validation is a Good Distribution Practice (GDP) requirement. It ensures that pharmaceutical products are consistently transported under conditions that maintain their

Stability Chamber
Documents

STABILITY CHAMBER IN PHARMA

Post Views: 4,333 A walk-in stability chamber is a controlled environment designed to simulate specific conditions such as temperature, humidity, and light to test the

MICROBIOLOGY DATA EVALUATION IN PHARMA
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MICROBIOLOGY DATA EVALUATION IN PHARMA

Post Views: 3,045 Microbiology data evaluation involves systematically reviewing, trending, and interpreting data generated from environmental monitoring, product testing, and utilities monitoring to ensure compliance

CRITICALITY EVALUATION OF INSTRUMENTS IN PHARMA
Documents

CRITICALITY EVALUATION OF INSTRUMENTS IN PHARMA

Post Views: 2,874 🧭 Criticality Evaluation of Instruments in Pharma ✅ What is Criticality Evaluation? Criticality evaluation is the process of assessing instruments to determine

Building Management System in Pharma
BUILDING MANAGEMENT SYSTEM

BUILDING MANAGEMENT SYSTEM IN PHARMA

Post Views: 2,786 ✅ What is a BMS? A Building Management System (BMS) is an integrated control system that monitors, controls, and records critical facility

ERP VALIDATION IN PHARMA
Documents

ERP VALIDATION IN PHARMA

Post Views: 5,067 ✅ What is ERP Validation? ERP (Enterprise Resource Planning) Validation means providing documented evidence that the ERP system: 🎯 Why is ERP

CQA
Documents

CORPORATE QUALITY ASSURANCE (CQA) SOP IN PHARMA

Post Views: 8,369 In general, large companies with multiple sites have one site that serves as “headquarters” for the corporation. It’s the place where (irrespective

GOOD TESTING PROCEDURE IN QC CHEMICAL
GTP IN QC CHEMICAL

GOOD TESTING PROCEDURE IN QC CHEMICAL

Post Views: 3,307 QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential

JOB DESCRIPTION IN PHARMA
JOB DESCRIPTION

JOB DESCRIPTION IN PHARMA

Post Views: 4,680 Job Descriptions in the pharmaceutical industry vary greatly depending on the role, but I’ll give you a clear template you can adapt

QUALITY CONTROL SPECIFICATIONS OF RAW MATERIALS
QUALITY CONTROL SPECIFICATIONS OF RAW MATERIALS

QUALITY CONTROL SPECIFICATIONS OF RAW MATERIALS

Post Views: 4,297 QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential

Qualification of IPQC Instruments in Pharma
Documents

QUALIFICATION OF IPQC INSTRUMENTS IN PHARMA

Post Views: 4,677 🧪 Qualification of IPQC Instruments in Pharma ✅ What are IPQC Instruments? IPQC (In-Process Quality Control) instruments are devices used during manufacturing

GOOD TESTING PROCEDURE FOR MICROBIOLOGY
Documents

GOOD TESTING PROCEDURE FOR MICROBIOLOGY

Post Views: 3,091 Good Testing Procedure (GTP) for Microbiology – Introduction Microbiological testing ensures products, materials, and environments comply with quality, safety, and regulatory standards.

Documents

USER REQUIREMENT SPECIFICATION FOR INJECTABLE

Post Views: 4,057 The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the

Documents

STABILITY IN PHARMA

Post Views: 4,679 Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental

Documents

MEDIA FILL IN PHARMA

Post Views: 6,880 A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium

Documents

MISCELLANEOUS DOCUMENTS IN PHARMA

Post Views: 3,377 Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.

Manufacturing in Pharma
BATCH MANUFACTURING & PACKING RECORDS

BATCH MANUFACTURING & PACKING RECORDS

Post Views: 7,398 Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is

USER REQUIREMENT SPECIFICATION FOR CHEMICAL INSTRUMENTS
Documents

USER REQUIREMENT SPECIFICATION FOR CHEMICAL INSTRUMENTS

Post Views: 5,442 Introduction: This User Requirement Specification (URS) defines the requirements for the selection, procurement, installation, qualification, and use of chemical instruments intended for

Site Acceptance Test (SAT)
Qualification

SITE ACCEPTANCE TEST (SAT)

Post Views: 5,459 All criticalities emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may

Microbiological Validations and Qualifications

MICROBIOLOGY INSTRUMENTS QUALIFICATION

Post Views: 5,258 Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology

API Qualifications
Qualification

API QUALIFICATIONS IN PHARMA

Post Views: 6,110 An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and

Qualification

AEROSOLS QUALIFICATIONS IN PHARMA

Post Views: 4,282 Pharmaceutical Aerosols are pressurized dosage forms containing one or more active ingredients which upon activation emit a fine dispersion of liquid and/or

Factory Acceptance Test
Qualification

FACTORY ACCEPTANCE TEST (FAT)

Post Views: 5,620 In the world of Pharmaceuticals, a Factory Acceptance Test (FAT) is simply a series of test for a newly manufactured equipment. With a Factory

URS for Microbiology

USER REQUIREMENT SPECIFICATION FOR MICROBIOLOGY

Post Views: 5,185 The User Requirement Specification for Microbiology (URS) is offered to help the user with the crucial facets of fabrication, facilities for installing

Hold Time Study in Pharma
Documents

HOLD TIME STUDY IN PHARMA

Post Views: 2 During Hold Time Study in Pharma, Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw

Microbiological Validations and Qualifications

MICROBIOLOGICAL VALIDATIONS AND QUALIFICATIONS

Post Views: 7,119 In the domain of microbiology, the process by which it is proven by laboratory tests that a method’s performance characteristics satisfy the

IPQA instruments in Pharma
IPQA

SOP FOR IPQA INSTRUMENTS IN PHARMA

Post Views: 5,688 By evaluating the tests for weight variation, hardness, and friability, for example, IPQA Instruments in Pharma assess the test results from in-process

Nitrogen System Generation and Distribution Qualification
Nitrogen Qualification

NITROGEN SYSTEM QUALIFICATION

Post Views: 44,629 Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric

Compressed Air System Qualification in Pharma
Compressed Air

COMPRESSED AIR QUALIFICATION IN PHARMA

Post Views: 10,128 Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil

Water System Qualification in Pharma
Water System Qualification in Pharma

WATER SYSTEM QUALIFICATION IN PHARMA

Post Views: 20,454 “Water” forms the most important ingredient in the pharmaceutical manufacturing process and also finds a major use in cleaning of equipment before

User Requirement Specification

USER REQUIREMENTS SPECIFICATION IN PHARMA

Post Views: 10,917 The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required

ENGINEERING SOP

ENGINEERING SOP IN PHARMA

Post Views: 32,594 Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also

Manuals

MANUALS IN PHARMA

Post Views: 4,350 The ISO 9001 standard for Quality Management Systems first called for manuals in pharma as part of its requirements. Top-level publications that

Human Resource (HR)

HR SOP IN PHARMA

Post Views: 13,108 The HR SOP in Pharma (HR department) of an organisation manages human resources and handles a variety of employment-related tasks, including hiring,

QUALITY ASSURANCE

SOP FOR QUALITY ASSURANCE IN PHARMA

Post Views: 7,775 One of the most significant elements of the entire medication production process is quality assurance in pharma. It will not only enable

Cleaning Validation

CLEANING VALIDATION

Post Views: 61,324 Cleaning Validation goal is to guarantee that cleaning procedures are effective in removing product residue, cleaning agent residue, and live microorganisms from

computer system Validation
Software Validation

COMPUTER SYSTEM/PLC/SCADA VALIDATION

Post Views: 48,588 In the pharmaceutical sector, CSV is crucial for enhancing product quality, improving process performance, and supporting high-quality goods. The primary advantage of

Quality Control

QUALITY CONTROL SOP

Post Views: 8,112 Pharmaceuticals must include quality control SOP as a crucial component. The World Health Organization (WHO) defines quality control (QC) as the total

Warehouse sop in pharma
WAREHOUSE

WAREHOUSE SOP IN PHARMA

Post Views: 1,021 When raw materials (Active & Excipients) and packing materials are received and stored under the necessary storage conditions, this is known as

Documents

INFORMATION TECHNOLOGY SOP IN PHARMA

Post Views: 26,868 Information technology SOP in Pharma are used in the pharmaceutical industry to generate, process, store, retrieve, and communicate many types of data

Utility
Utility

UTILITY IN PHARMA

Post Views: 4,806 Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support

Quality Risk Assessment
Quality Risk Assessment

QUALITY RISK ASSESSMENT IN PHARMA

Post Views: 91,321 In the pharmaceutical industry, quality risk assessment in pharma entails the identification of hazards as well as the investigation and assessment of

PROCESS VALIDATION

PROCESS VALIDATION

Post Views: 12,420 Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production,

Safety

SAFETY SOP IN PHARMA

Post Views: 9,536 Every workplace has a specific set of hazards, and safety SOP in Pharma can help. The pharmaceutical manufacturing sector entails a variety

LVP
Large Volume Parenteral

LARGE VOLUME PARENTERAL EQUIPMENTS QUALIFICATIONS IN PHARMA

Post Views: 4,072 Large volume parenteral equipments qualifications in pharma play a significant role. Injectable aqueous medication products that have been terminally sterilized (autoclaved) and

Form Fill Seal
Form Fill Seal

FORM FILL SEAL EQUIPMENTS QUALIFICATIONS IN PHARMA

Post Views: 4,192 Form Fill Seal Equipments qualifications in Pharma are crucial. To prepare sterile items, form fill seal (FFS) technology uses automated computer control.

Ampoules
Ampoules

AMPOULE EQUIPMENTS QUALIFICATION

Post Views: 4,088 Ampoule Equipments Qualification plays important role in pharma. An ampoule, also known as an ampul or an ampule, is a tiny sealed

Opthalmics
Opthalmics

OPTHALMICS EQUIPMENTS QUALIFICATIONS

Post Views: 2,998 Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Opthalmics (Eye drops) are liquid drops that are often applied in small volumes,

Oral Liquid
oral liquid qualifications

ORAL LIQUIDS QUALIFICATIONS IN PHARMA

Post Views: 7,217 Oral liquids in Qualifications in Pharma are crucial. Pharmaceuticals include syrup, oral suspension, oral solution, oral drop, oral emulsion, mixture, linctus, and

Ointment
Ointments

OINTMENTS QUALIFICATIONS IN PHARMA

Post Views: 5,552 Ointments qualifications in pharma plays a significant role. Ointments are cosmetic products that are applied externally to the skin. When applied to

Softgel Capsules
Documents

SOFTGEL CAPSULES QUALIFICATIONS IN PHARMA

Post Views: 3,441 Softgel Capsules Qualifications in Pharma plays important role in pharma. A Softgel Capsules have an exterior shell made of solid material that

HARDGEL CAPSULES QUALIFICATIONS

HARDGEL CAPSULES QUALIFICATIONS

Post Views: 4,691 Hardgel Capsules Qualifications plays important role in pharma. Hardgel Capsules are solid dose forms that contain one or more active ingredients and/or

tablets qualifications in pharma

TABLETS QUALIFICATIONS IN PHARMA

Post Views: 8,845 Tablets Qualifications in Pharma plays important in pharma. Tablet is an oral solid dose form for medications (OSD). Tablets are a solid

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