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...
down the procedure for the line clearance of the area / equipment.
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...
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.
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...
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 :
is a portion of...
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
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...
lay down the procedure for
handling of Planned Modification System.
2. Scope :
SOP is applicable to addition, deletion &/or modification of area,
equipments, utility, system, machines.
3. Responsibilities :
Department, QA, Engineering
Modification: A modification which
is planned for...