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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