Description:

• Computer system validation provides documented proof that the system (e.g. Hardware, software, peripherals and network) will repeatedly and reliably do what it is designed to do, is “fit-for-purpose”, and complies with the applicable rules and regulations.
• Validation of computerized systems according to GxP Guidelines (CSV) has been a basic requirement in the healthcare industry for many years.
• Computer system validation is definitely not a “one size fits all” procedure; the approach that an individual company may take to a specific validation depends on the rules, guidance, best practices, and characteristics of the system being validated.

Good Manufacturing Practice

Description:

WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”. GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints. The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made.

Deviation Handling

Description

During the normal process of vaccine manufacture, deviations from documented, approved processes may occur. These may be planned or unplanned. Although manufacturers do their best to avoid these deviations they are naturally unavoidable. These deviations may impact on the quality of the product. It is important for a manufacturer to have a documented and systematic approach to deviation handling and assessing risk to the quality of the product.

Pharma Change Control

Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.

• Issues related to personnel, as well as facilities, equipment, documentation, process control, quality control, drug sales, complaints and reviews activities and self-inspection activities should be regularly reviewed in accordance with a pre-approved program on a specific schedule for checking their compliance with the principles of quality assurance.

• Self-inspection should be carried out independently and carefully by specially appointed qualified (s) person (s), who are (them) in the state of the enterprise. If necessary, an independent audit by third-party experts can be carried out.
•  Self-inspection results should be documented. The reports should include all the observations made during the audit, and, where applicable, suggestions for corrective actions. Actions taken as a result of self-inspections should also be documented.

OOS OOT Investigation

Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.

• Issues related to personnel, as well as facilities, equipment, documentation, process control, quality control, drug sales, complaints and reviews activities and self-inspection activities should be regularly reviewed in accordance with a pre-approved program on a specific schedule for checking their compliance with the principles of quality assurance.

• Self-inspection should be carried out independently and carefully by specially appointed qualified (s) person (s), who are (them) in the state of the enterprise. If necessary, an independent audit by third-party experts can be carried out.
•  Self-inspection results should be documented. The reports should include all the observations made during the audit, and, where applicable, suggestions for corrective actions. Actions taken as a result of self-inspections should also be documented.

Self Inspection

Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.

• Issues related to personnel, as well as facilities, equipment, documentation, process control, quality control, drug sales, complaints and reviews activities and self-inspection activities should be regularly reviewed in accordance with a pre-approved program on a specific schedule for checking their compliance with the principles of quality assurance.

• Self-inspection should be carried out independently and carefully by specially appointed qualified (s) person (s), who are (them) in the state of the enterprise. If necessary, an independent audit by third-party experts can be carried out.
•  Self-inspection results should be documented. The reports should include all the observations made during the audit, and, where applicable, suggestions for corrective actions. Actions taken as a result of self-inspections should also be documented.

Cleanroom Behavior

The aim of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients, and/or cleaning agents as well as the control of potential microbial contaminants. In addition one needs to ensure there is no risk associated with cross-contamination of active ingredients.

Steam Sterilization
Principles, Operation and Validation

We understand that analytical method validation are extremely important in the development of our clients’ products. Analytical methods must be validated to provide reliable data for regulatory submissions. With years of experience, our team gives support to the development of these methods to ensure compliance with quality and safety standards. We have gained confidence with our clients by providing accurate and reproducible results.

CTD Preparation

We understand that analytical method validation are extremely important in the development of our clients’ products. Analytical methods must be validated to provide reliable data for regulatory submissions. With years of experience, our team gives support to the development of these methods to ensure compliance with quality and safety standards. We have gained confidence with our clients by providing accurate and reproducible results.

Analytical Method Validation

We understand that analytical method validation are extremely important in the development of our clients’ products. Analytical methods must be validated to provide reliable data for regulatory submissions. With years of experience, our team gives support to the development of these methods to ensure compliance with quality and safety standards. We have gained confidence with our clients by providing accurate and reproducible results.

Analytical Method Validation

We understand that analytical method validation are extremely important in the development of our clients’ products. Analytical methods must be validated to provide reliable data for regulatory submissions. With years of experience, our team gives support to the development of these methods to ensure compliance with quality and safety standards. We have gained confidence with our clients by providing accurate and reproducible results.

Process Validation

A process is the controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. The process validation protocol describes a plan that demonstrates consistency and reliability in processing and confirms that all component, processing and product specifications are appropriate and attainable under ideal and challenged conditions. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically at a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation.

Good Documentation Practices

A process is the controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. The process validation protocol describes a plan that demonstrates consistency and reliability in processing and confirms that all component, processing and product specifications are appropriate and attainable under ideal and challenged conditions. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically at a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation.