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expert pharma Qualification Service

Ensure Compliance and Quality with our
Expert Pharmaceutical Qualification Service

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Qualification service are a critical component of ensuring quality and safety in the pharmaceutical industry. These services involve assessing and verifying that equipment, facilities, processes, and systems used in the manufacture of pharmaceutical products meet industry standards and regulatory requirements. There are several stages involved in pharmaceutical qualification, including:

This stage involves ensuring that the design of a pharmaceutical product, equipment or facility  is suitable and meets the intended purpose. During this stage, the design of the product is reviewed to ensure that it meets the regulatory and customer requirements. suitable and meets the intended purpose.

This stage involves ensuring that the equipment or facility is installed correctly and according to the design specifications. During this stage, the installation process is reviewed to ensure that it meets the regulatory and customer requirements.

This stage involves ensuring that the equipment or facility operates as intended and within the specified range. During this stage, the equipment or facility is tested to ensure that it operates within the specified limits.

This stage involves ensuring that the equipment or facility consistently performs as intended and meets the specified requirements. During this stage, the equipment or facility is tested to ensure that it performs consistently and reliably over time.

This stage involves ensuring that the equipment or facility continues to meet the intended purpose and specifications over time. Regular requalification is necessary to ensure that the equipment or facility remains in compliance with the regulatory and customer requirements.

Our Pharma Qualification Service

We offer a range of services to ensure that equipment, facilities, and processes meet the highest quality standards and comply with regulatory requirements.

Equipment Qualification

Equipment Qualification

Ensuring that equipment used in the manufacture of pharmaceutical products is functioning as intended and meets industry standards.

Facility Qualification

Facility Qualification

Ensuring that the facility used in the manufacture of pharmaceutical products is designed, built, and maintained to meet regulatory requirements and industry standards.

Process Qualification

Process Qualification

Ensuring that the manufacturing process used to produce pharmaceutical products is consistent, reliable, and meets regulatory requirements and industry standards.

Qualification Services

Benefits of hiring us for your Qualification Service

Our Qualification Services Guarantee Unmatched Quality Standards

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Our Comprehensive Approach to Qualification Services in the Pharmaceutical Industry

FAQ's

1.What is pharmaceutical qualification?
Pharmaceutical qualification is the process of ensuring that equipment, facilities, processes, and systems used in the manufacture of pharmaceutical products meet the highest quality standards and regulatory requirements.

 

2.What are the benefits of pharmaceutical qualification service?
The benefits of pharmaceutical qualification include:

Improved quality and safety of pharmaceutical products
Reduced risk of recalls and product failures
Increased compliance with regulatory requirements
Reduced costs of manufacturing
Increased efficiency of operations

 

3.What are the different types of pharmaceutical qualification?
There are four main types of pharmaceutical qualification:

Equipment qualification (EQ)
Facility qualification (FQ)
Process qualification (PQ)
System qualification (SQ)

 

4.What are the steps involved in pharmaceutical qualification?
The steps involved in pharmaceutical qualification vary depending on the type of qualification being performed. However, the general steps include:

Planning and scoping
Risk assessment
Design verification
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Documentation

 

5.What are the regulatory requirements for pharmaceutical qualification?
The regulatory requirements for pharmaceutical qualification vary depending on the country and the type of pharmaceutical product. However, the general requirements include:

The qualification must be performed in accordance with a written procedure
The qualification must be documented
The qualification must be reviewed and approved by a qualified person

 

6.What are the costs of pharmaceutical qualification?
The costs of pharmaceutical qualification vary depending on the type of qualification being performed, the complexity of the equipment or facility, and the regulatory requirements. However, the costs can be significant.

 

Contact us today for Qualification Services

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