Overview

The world of Life sciences is moving towards procedural standardization, risk-based methodology, quality by design (QbD) and common control framework. However, Standard Operating Procedures (SOP) writing and SOP review may sometimes, require organizations to invest a lot of time and money to research about global legislations and to perennially update the systems. In such scenarios, organizations lookup for expert SOP writing services and SOP review services.

Freyr can provide SOP writing  and SOP review services for all types of Pharmaceutical practices, Research and Development, Annual Product Quality Review (APQR SOP), Information Technology Regulatory Affairs, Quality Management Review, Clinical Research and all categories of pharmaceutical SOPs.

With a comprehensive knowledge on new SOP writing /SOP review or to amend/standardize existing ones, Freyr, with the help of its expert team, offers end-to-end SOP writing and SOP review services that span across: 

SOP Writing Services

SOP Review Services

SOP Integration Services

  • Process designing and establishment by writing SOPs for a new management system
  • SOP writing for existing management system (for new and target processes)
  • Review of existing SOPs for accuracy and providing gap analysis report
  • Review of existing SOPs for accuracy and providing Remediation report
  • SOP Reconciliation Services (Standardization, Rationalization, Optimization)
  • For mergers and acquisitions

Integrated Process of multiple management systems (ISO 9001, ISO 27001 with USFDA, EMEA, MHLW)

 

Freyr Expertise

SOP Gap Analysis

Freyr has been providing SOP writing services for Pharma, Healthcare and Biotechnology industries. In last 5 years, Freyr Compliance & Validation Centre of Excellence (CoE) has created/reviewed/harmonized 5500+ SOPs for its customers and continues to support them.

Following the risk-based approach and common control framework methodologies, Freyr support organizations with integrated SOPs catering to all Regulatory requirements which they fall under. Freyr’s expert group of QMS remediation can establish process architecture by integration of multiple regulations for unified management systems (ISO 9001, ISO 27001, GLP - 17025, Medical Laboratories - 15189, CAP with USFDA, EMEA, MHLW, WHO, GxP, ICH).

  • Process designing
  • Establishing process architecture
  • Risk-based approach
  • Common control framework
  • Integration of multiple regulations for unified management systems

Additionally, Freyr has catered audit and audit readiness support (including SOP writing) for 20+ Large/Medium/Small Pharma companies with global health authorities including USFDA, MHRA, EMA, CDSCO, ANVISA, SFDA, HALMED, NPRA, HSA, Health Canada and 20+ other health authorities.

Process Approach for Updating and Creating SOPs

Process Approach for Updating and Creating SOPs

SOP Authoring and Review

SOP Authoring And Review

Customer Review and Sign Off

Customer Review and Sign Off

Overview of the SOP writing department, Compliance & Validation

Overview od the SOP writing department, Compliance & Validation

Level & Experience at Freyr for SOP writing

Level & Experience at Freyr for SOP writing

SOP Review Services

While expanding businesses to newer markets, Life sciences organizations are required to develop new SOPs based on the regional Regulatory requirements or should update/upgrade the existing processes to align them with new demands. But prior to SOP development, it is indeed the right approach to identify the gap between processes and remediate them accordingly.

Freyr is experienced in a range of projects on SOP review services. The simplest of the service offering is to review existing SOPs for accuracy and providing gap analysis report to complex projects, which involve SOP review and remediation resulting in SOP standardization, rationalization or optimization.

SOP Standardization

As the business grows, the standards to be followed or adhered will also increase. There will be times when a customer falls under so many standards and regulations to follow, which may include SOP for safety in the pharmaceutical industry. In such scenarios, maintaining and following different streams of SOPs for each standard will double up the procedural complexities for companies. The need of the hour is to unify or standardize the SOPs.

SOP Rationalization

At times, organizations create Standard Operating Procedures to just let go of the audit. But alas, those SOPs are hardly of any use to implement. Either they are not followed by employees or they could make processes complex, if integrated. To avoid such situations, it is needed to rationalize the SOPs that bring some value to organizations’ time and resources.

Supporting organizations to come off writing SOPs to just pass through the audits; Freyr provides Standard Operating Procedure review services and rationalizes them in addition to adhering with applicable regulations and assists organizations to get succeed in the SOP compliance audit. Thus, to bring-in real value to the company.

SOP Reconciliation and Optimization

Though there is no set guideline, as a general practice, SOPs must be reviewed at defined and periodic intervals. With different formats and versions accumulate, there is always a chance for overlapping and duplication. During such times, organizations are required to showcase they continuously reconcile the SOPs while optimizing continually improving processes to support their growth and business.

With a clear-cut knowledge on SOPs and quality systems, Freyr assists organizations to reconcile and optimize the SOPs, periodically. Freyr’s expert compliance team can monitor and carry out incremental updates.

SOP Integration

Mergers and acquisitions are an integral part of today’s business scenario. But when they take place, bringing together and managing the procedures, standards, standard operating procedures, and quality systems of both the organizations could be grueling. In addition to aligning the existing standards, setting up SOPs for the newly formed organization will be even more hectic, especially when it is to come into existence within short turnaround time.

Having an expert compliance team in-house, Freyr offers end-to-end SOP integration services to analyze the gaps between both the organizations’ systems, standardize existing systems and design new SOPs, if needed. Freyr’s experts extend full system integration support for designing seamless processes and workflows.

 

Freyr Advantages

  • Proposing cost-effective process options without compromising the objective of product quality, Regulatory compliance, patient safety, data integrity and security
  • Integrated process models
  • Proven practicable validation and qualification strategies
  • Quick turnaround time