PharmaState Is Official Media Partner For DUPHAT 2022. Click the banner to explore more...spot_imgspot_imgspot_img

Quality Manual

A quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your...

SOP For Line Clearance

Objective:   To lay down the procedure for the line clearance of the area / equipment. 2. Scope: This SOP is applicable to all stages of manufacturing operations carried out before the start of operation/stage during the manufacturing/packing to avoid any...

CVP : Cleaning Validation Protocol

Adequate cleaning procedures play an important role in preventing contamination & cross-contamination. Validation of Cleaning Methods provides documented evidence that an approved cleaning procedure will provide clean equipment, suitable for the intended use. Cleaning Validation...

Lean & Six Sigma Methodology – Basics

Lean Methodology    The companies’ need for constant improvement and evolution leads to the search of management tools and methods to foster the development of customer service and to reduce the costs for all associated...

SOP for Sampling

1.Objective :    To lay down the procedure for sampling of intermediates, drug substances, drug products. 2. Scope :     This procedure is applicable for Pharmaceutical Industry of API as well as formulations. 3. Definition : Sample: Sample is a portion of...

Quality Agreements – PART 2

Quality Agreement From a cGMP perspective, manufacturing activities are the most important element in a quality agreement. The most critical pieces are quality and change control, as described in the following sections 2....

Quality Agreements – PART 1

What Is a Quality Agreement? A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply...

SOP – Planned Modification

1.Objective: To lay down the procedure for handling of Planned Modification System. 2. Scope : This SOP is applicable to addition, deletion &/or modification of area, equipments, utility, system, machines. 3. Responsibilities : User Department, QA, Engineering 4. Definitions: Planned Modification: A modification which is planned for...

Recent posts

Popular categories