Production
Moisture Analyzer Balance – Operation & Calibration
Standard Operating Procedure for Operating, Calibrating and Cleaning of Moisture Analyzer Balance used to determine the moisture content in bulk… Read More
Auto Coater – Operation & Cleaning Procedure
Standard Operating Procedure for Operation and Cleaning of Auto Coater - Automatic Coating Machine used for Tablet Coating during manufacturing… Read More
Fluidized Bed Dryer (FBD) – Operation & Cleaning
Standard Operating Procedure and Guideline for Cleaning & Operation of Fluidized Bed Dryer (FBD) and Finger Bags (FBD Bags) which… Read More
Rapid Mixer Granulator (RMG) – Operation & Cleaning
SStandard Operating Procedure (SOP) and Guideline for Operation and Cleaning of Rapid Mixer Granulator (RMG) used in granulation section of… Read More
In Process Quality Control (IPQC) Check Procedure
Guideline for In Process Quality Control (IPQC) check during manufacturing of different pharmaceutical dosage form like Oral Liquid, Tablets &… Read More
Out of Trend (OOT) Results in Stability Study
Standard Operating Procedure (SOP) for Handling of Out of Trend (OOT) results during Stability Study of Drug Product. Out of… Read More
Hold Time Study of Pharmaceutical Products
Standard Operating Procedure & Guideline for Hold Time Study of Drug Product at different manufacturing stages like bulk granules/powder, blend,… Read More
New Product Introduction Procedure and QRM
Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality… Read More
Technology Transfer Procedure of Drug Product
Guideline for Technology Transfer. Tech Transfer is a systematic procedure that contains the transfer of any process together with its… Read More
Market Complaint Handling Procedure of Drug Product
Standard Operating Procedure (SOP) & Guideline for Handling of Market Complaint of Drug Product. Any complaint, written or verbal, received… Read More
Acceptable Quality Limit (AQL) Procedure & Chart
Standard Operating Procedure (SOP) and Guideline for the classification of different types of Quality defects that may be encountered in… Read More
Quality Risk Management (QRM) – ICH Q9
Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and… Read More
Batch Manufacturing Record (BMR) Management
Standard Operating Procedure for Preparation, Checking, Approval, authorization & issuance of Master Formula Record, Batch Manufacturing Record (BMR) & Batch… Read More
Cleaning Validation (CV) Procedure and Protocol
Standard Operating Procedure (SOP) and Guideline for performing Cleaning Validation (CV) of drug product manufacturing equipments. Cleaning Validation (CV) 1.0 … Read More
Process Validation (PV) & Verification of Drug Product
Standard Operating Procedure (SOP), Guideline and Protocol for Process Validation and Verification for Drug Product (Tablet, Capsule etc.) Process Validation… Read More
Deviation (Planned and Un-planned) Control System
Standard Operating Procedure (SOP) for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging, or… Read More
APQR – Annual Product Quality Review in Pharma
Standard Operating Procedure for Annual Product Quality Review (APQR), also known as Product Quality Review (PQR) and Annual Product Review… Read More
Mock Recall and Drug Product Recall Procedure
Standard Operating Procedure for Mock Recall and Drug Product Recall, The drug product recall is a process of removal or… Read More
Change Control Process and Management in Pharma
Standard Operating Procedure (SOP) for Procedure, Process and Management of Change Control (temporary change or permanent change control) in the… Read More
Stability Study of Drug Product as per ICH Q1A(R2)
Standard Operating Procedure (SOP) for Stability Study of Drug Product as per ICH Q1A(R2). The term (Stability Study) with respect… Read More