GxP compliance services in pharmacy helps to ensure pharmacy companies meet industry regulations and come up with products that are safe and exactly meet all quality standards throughout the production process i.e. from document creation for risk-based C&Q, validation of manufacturing, and cleaning processes to routine production. However, the challenge lies in interpreting it correctly and putting it to practice.
Outsource2india has over 2 decades of experience in providing pharma companies with high standards of GxP services. We have a team of experts who have in-depth knowledge in pharma-related GxP and experience in assisting several pharma companies to implement and follow the right GxP standards.
GxP Compliance Services We Offer
As a specialized GxP Compliance company, We offer a range of GxP services to pharmaceutical companies around the world. Some of these exclusive services include -
We specialize in comprehensive advisory services for pharma companies. This includes proving gap analysis views to industry veterans looking for feedback. Some of our exclusive GxP Compliance Consulting services include -
- Advising on gap analyses to identify regulation violations
- Evaluating process flow correctness for CGMPs
- Providing advisory support to Project Managers and QA Managers
- Training employees in research techniques and regulatory requirements
- Developing clinical trial materials labeling
- Carrying out due diligence of floor operations and other systems
- Liasoning between contractors who support, manufacturing operations, laboratories, and distribution centers)
- Preparing consent decree remediation and verification activities and warning letter responses
- Monitoring manufacturing processes as part of regulatory requirement
- Assisting new companies in initiating manufacturing operations and maintaining quality assurance
- Developing strategic plans and regulatory strategies for interacting with governing bodies
- Overlooking communications, meetings, and regulatory submissions with governing bodies
Our audit services are driven by wide knowledge, experience, and understanding of the drug manufacturing process. Our GxP service audits to come with the following features -
- Comprehensive Audit Report - Our audit reports cover audit needs as required by governing bodies with a summary table and color ratings that highlight classified information according to criticality.
- Dedicated Account managers - We offer a dedicated auditor for each of our customers, with support from a team of junior auditors and support in more than six languages.
- Cost-Effective Audits - We offer all our clients audits with an all-inclusive pricing model that passes on the benefits of quality at great cost savings.
Our services also entail providing subject matter training, fraud investigations, and internal evaluation. Each of these processes is documented to assist your legal counsel take up matters whenever issues arise. To ensure data integrity accuracy we assist you with -
- Classifying data by its value, sensitivity, and criticality to determine baseline security controls for the protection of your data.
- Keep track of data flow, monitor data collection, and data transfer process, and oversee the process of data usage, data retention, and backup.
- Assist you with developing a regulated environment with access controls for systems handling data so that only authorized people can handle data.
- Conduct training of all employees handling data, to inculcate a sense of data integrity principles and enlighten them on identifying possible data integrity issues.
- Assistance concerning remedying possible data integrity issues by developing work procedures, to describe and guides your end-to-end data flow processes.
To assist you to stay compliant and improve continuously we partner with businesses such as clinical studies, pharmaceutical producers, medical device developers, and laboratory service providers to assist them to align with new and changing regulations that keep evolving throughout the lifecycle of the drug product and device development. We assist our clients to meet GxP Compliance requirements in the following ways -
- Conduct mock inspections, supplier audits, internal audits, and gap assessment audits with the help of specialists such as CQA certified auditors and former FDA inspectors.
- Carry out inspections to understand, evaluate and identify systems for quality improvements for front/backroom support, application conformance, readiness assessments, etc.
- We team up with your Quality Department for assisting with vendor auditing or inspecting site presentations, hosting processes, and tour routes.
- Assist you with inspecting your warehouses and distribution practice of logistic operators, to ensure storage and distribution is done as per best practices and without any loopholes.
Documentation is an important aspect of ensuring GxP compliance. As per governing body requirements, all pharmaceutical companies must have in place and maintain procedures for documents management for ensuring a quality system in place. Our documentation specialists have vast expertise in assisting pharmaceutical companies to develop validation protocols, SOPs, reports, annual product reviews, audit responses, FDA correspondence, and other technical reports.
Other Services You Can Benefit From
Benefits of Outsourcing GXP Compliance Services
There are several advantages of engaging an offshore consulting firm to carry out a comprehensive GxP compliance services audit program. Some of these include -
Outsourcing GxP compliance services audit help you save a lot on costs. The costs involved in hiring experienced and domain-based auditors are always very high.
Minimize Staff Involvement
By hiring third-party GxP service providers you can bring down the number of full-time staff needed to carry out an audit function without compromising on the objective of the audit.
Access to Skilled Auditors
Outsourcing helps you get easy access to a large pool of experienced auditors with considerable exposure to industry requirements.
Access Auditors with In-depth Expertise
Drug companies have limited resources in this area which is duly filled in by third-party agencies. These agencies device management experts to support their auditors or internal auditors, and thereby provide the additional expertise and mentorship needed.
Third-party agencies have auditors from several geographic locations. Therefore, agencies hire auditors from a region of their choice to maximize efficiency and reduce costs.
Quality and Standard Audits
Third-party agencies have well-developed and exhaustive processes to carry out audits. These audits are based on standard and proven practices and are developed over time with every tweak in compliance requirements.
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The verifications are going well. Anytime there is an issue or something additional we need, it gets addressed and usually gets corrected quickly. We appreciate your follow-up. Thank you so much.Leading Doctor, Kids Dental Clinic, Tampa, FL More Testimonials »
Outsource GxP Compliance Services to Outsource2india
Outsource2india has over 25 years of experience in compliance services. We are driven by experts with in-depth knowledge and expertise in all GxP areas that you may need to comply with regulatory requirements. Our targeted compliance management process entails a host of end-to-end requirements i.e. from document creation to data integrity, from auditing to inspection, and from advisory to mock drills for regulatory checks.
If your business is looking for comprehensive end-to-end GxP compliance services in India, get in touch with our experts now.
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- O2I Processed Over 3000 Encounters Related to Rehabilitation Care for a Group of Physicians from Indianapolis