GXP Services

Comprehensive GXP Services for Regulatory Compliance

GXP services, which stand for Good X (e.g., Manufacturing, Laboratory, Clinical, Documentation) Practices services, are a critical component in highly regulated industries like pharmaceuticals, biotechnology, and healthcare. These services ensure compliance with strict regulatory requirements and standards such as FDA regulations, GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and GCP (Good Clinical Practices). GXP services encompass a wide range of activities, including validation of equipment and systems, quality assurance, documentation management, and training to guarantee product safety, efficacy, and data integrity. By adhering to GXP standards, organizations can maintain operational excellence, product quality, and regulatory compliance throughout their entire product lifecycle.”

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why is GXP Services?

GXP services, which encompass various “Good X Practices” (e.g., Good Manufacturing Practices – GMP, Good Laboratory Practices – GLP, Good Clinical Practices – GCP), are essential in highly regulated industries such as pharmaceuticals, biotechnology, and healthcare. These services exist to ensure that organizations adhere to strict regulatory requirements and industry standards set forth by agencies like the FDA (Food and Drug Administration).

Our GXP Services include:

Computer System Validation (Data Integrity Assurance)

Computer System Validation (CSV) is an indispensable process ensuring that computerized systems in regulated industries, like pharmaceuticals and medical devices, meet reliability, consistency, and regulatory requirements. Industry standards such as GAMP 5 (Good Automated Manufacturing Practice) and EU Annex 11, alongside U.S. regulatory mandate 21 CFR Part 11 for electronic records and signatures, shape the CSV landscape.GAMP 5 adopts a risk-based approach, encompassing phases like planning, specification, design, testing, and maintenance. Planning defines the validation scope and functions requiring validation, specification outlines functional and performance requirements, and design involves detailed specifications.

Testing under GAMP 5 includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), ensuring correct installation, normal operation, and performance in various conditions.

EU Annex 11, a European Union requirement, demands validation, data integrity, and controlled system changes.

21 CFR Part 11, a U.S. regulation, enforces security, reliability, and accuracy of electronic records and valid electronic signatures, applying to all computerized systems in regulated industries.

We utilize the V-model of GAMP-5 for software qualification. Altogether, GAMP 5, EU Annex 11, and 21 CFR Part 11 create a comprehensive framework for ensuring the reliability, consistency, and compliance of computerized systems. CSV is pivotal in ensuring these systems operate effectively and meet regulatory standards.

Our expert team specializes in software validation according to GAMP-5, EU Annex 11, and 21 CFR Part 11. Here is a list of software successfully validated by our team:

LIMS
SAP
Track Wise (e-QMS)
BMS
Empower-3, Chromeleon 7.3
Lab solution, Tiamo, Autopol, Lab X, Mass Hunter
SCADA, PLC
Other Production and Laboratory software”

Operational Excellence

Operational Excellence is a management philosophy rooted in continuous improvement, fostering efficiency, waste reduction, and the delivery of safe, high-quality outputs. In Good Manufacturing Practices (GMP), it denotes optimizing processes, systems, and personnel for consistent high-quality product delivery while curbing waste, lowering costs, and upholding regulatory compliance in pharmaceutical, biotechnology, and medical device sectors. Vital for success, it enhances customer satisfaction, mitigates operational risks, and boosts profitability. It involves outpacing competitors by delivering products or services faster, with superior quality, and at reduced costs, thus sustaining growth and competitive edge.

Management systems, particularly in quality and knowledge domains, drive organizational improvement, uncovering short and long-term enhancement opportunities. Operational Excellence is an ongoing journey, demanding adaptability and agility in the ever-evolving business landscape.

Cultivating a culture of continuous improvement, via training, process reviews, and innovation, is crucial. It demands a commitment to long-term goals over short-term gains, reinventing operations, and embracing change.

Our Operational Excellence service encompasses Process Simplification, Productivity Enhancement, and OEE improvement, pivotal for sustained business success.

Following are the areas that we support organizations to attain operational excellence.

Reduce Paperwork (Automating the process)
Standardize processes (Mastering complexity through simplification)
Improve the lifetime of the assets
Integrate all technologies
OEE improvement
Cybersecurity

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Site Remediation

A site remediation project is a strategic initiative aimed at addressing non-compliance issues within manufacturing facilities or across multiple sites, encompassing manufacturing, laboratory practices, and various processes. Such projects can be initiated in two primary ways: through a proactive review of practices against regulatory standards or reactively in response to regulatory actions, such as an FDA-483 observation or the issuance of a Warning Letter by the Food and Drug Administration.In a Warning Letter, the FDA outlines violations identified during a recent inspection and provides the pharmaceutical company with a ten-day window for initial response and a thirty-day timeframe to submit a comprehensive remediation plan. These projects are instrumental in ensuring regulatory adherence and the continual improvement of practices within the pharmaceutical industry

Our experts provide remediation services for Data integrity issues, Quality culture revamping, QMS redeployment, Risk assessment, Green field project.

Data Integrity Issues: We specialize in resolving data integrity challenges, ensuring the accuracy, completeness, and reliability of critical data across your operations.
Quality Culture Enhancement: Our services encompass the revitalization of your organizational culture to prioritize and embed a strong quality ethos.
QMS Redeployment: We assist in the strategic redeployment of Quality Management Systems (QMS) to optimize processes and adherence to regulatory standards.
Risk Assessment: Our experts conduct comprehensive risk assessments to identify and mitigate potential issues, safeguarding your operations.
Greenfield Project Support: We provide guidance and support for greenfield projects, ensuring they are planned and executed in alignment with best practices and compliance requirements.”

GMP Audit

GMP audit services encompass the evaluation of an organization’s adherence to Good Manufacturing Practices (GMPs). GMPs consist of essential guidelines and regulations governing the consistent and controlled production of pharmaceuticals, medical devices, and food products to uphold stringent quality standards. The primary objective of a GMP audit is to guarantee the safety and consistent quality of products, ensuring they meet customer expectations—consistency in appearance and functionality with each production cycle.

Our GMP audit services deploy a proficient team of auditors equipped to scrutinize an organization’s manufacturing processes, documentation, facilities, and quality control procedures for GMP compliance. The audit results in a comprehensive report of findings and, where necessary, recommendations for enhancement. GMP’s quality systems approach encompasses the assessment of five critical subsystems: Production, Materials, Facilities and Equipment, Packaging/Labeling, and Laboratory Controls. Our seasoned auditors possess in-depth knowledge of GMP requirements and remain up-to-date with the latest industry standards and regulations. GMP audit services serve as a pivotal mechanism for safeguarding the quality and safety of pharmaceuticals, medical devices, and food products.Our services for GMP Audit include:
Third Party Audit

Data Integrity
Gap assessment
Pre and post inspection audit
Pre and post inspection audit
FDA (MOCK) audit

Vendor Audit

Vendor identification
Vendor development:
Vendor approval
Periodic audit
FDA (MOCK) audit

Training and People Development

Training and people development are integral to a successful Good Manufacturing Practices (GMP) program. Competency assessments tailored to individual job responsibilities identify precise training needs.

The rapid evolution of technology profoundly impacts the pharmaceutical industry, reshaping medical practices, production methods, healthcare systems, and patient expectations. Hence, it’s vital that pharmaceutical staff comprehend these shifts, especially frontline employees who serve as trusted customer touchpoints.

Effective training strategies are essential.

Bite-sized modules capture employee attention when disseminating extensive information. Mobile-friendly learning enhances accessibility, seamlessly integrating training into the workday. Mobile training’s appeal also lies in its real-time information updates, ensuring employees stay current on new procedures and drug production.”In a Warning Letter, the FDA outlines violations identified during a recent inspection and provides the pharmaceutical company with a ten-day window for initial response and a thirty-day timeframe to submit a comprehensive remediation plan. These projects are instrumental in ensuring regulatory adherence and the continual improvement of practices within the pharmaceutical industry

Training on cGMP, GDP, or GLP
Training on Audit Behavior and FDA audit readiness
Training on Computer System Validation (CSV) and Cybersecurity Assessment (CSA)
Training on human error reduction
Training on scientific investigations
Soft skill and leadership training
On-demand training (Tailored training modules as per customer requirement)

INFISTAQ

HRstaq

VendorStaq

RecruitStaq

AssetStaq

AppreXA

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TASKDA

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GXP Services

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Our GXP Services include:

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