Having the appropriate Quality Management System in place and complying with Good Manufacturing Practices (GMP) requirements or with ISO 13485 requirements is mandatory for both pharmaceutical companies and medical device companies before getting their products approved by health authorities. Additionally, pharmaceutical and medical device companies must maintain the same quality management system during the whole lifecycle of their products.
Many pharmaceutical and medical device companies encounter many challenges during the implementation and or maintenance of the required quality management system due to luck of expertise or shortage in resources.
Global Regulatory Partners Inc., (GRP) Quality Team has the required skills , experience and certifications to assist pharmaceutical and medical device companies develop the required quality standard operating procedures (SOPs), implement and maintain the appropriate quality management system to be in compliance with GPM or ISO13485 requirements through the whole products cycle. GRP Certified Quality Auditors can help you prepare for FDA inspections and response to 483
Preparation for FDA Inspections
Every manufacturer or processor of FDA-regulated products such as pharmaceuticals, biologics API, or medical devices, is subject to FDA inspections. The purpose of FDA inspections is to verify companies’ compliance with all relevant regulations and help protect the public from the use of unsafe products. FDA’s inspection authority also extends to foreign manufacturing and processing sites for FDA-regulated products sold in the United States.
There are four different types of FDA inspections: pre-approval inspections (PAI), routine inspections, compliance follow-up inspections, and “for cause” inspections.
Pre-Approval Inspections (PAI) are conducted after a company submits to FDA a New Drug Application (NDA), or New Biologic Application (BLA) , or a Premarket Application for a New Medical Device (PMA) before marketing the new product in USA. PAI inspections focus on verifying data included in the application and confirming that the facility is capable of manufacturing said product. The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval of the new product.
Routine Inspections are mandated by law every 2 years for every pharmaceuticals, Biologics, APIs and class II and class III device manufacturers. They follow a prescribed method known as Quality System Inspection Technique (QSIT). If a serious public health risk is identified during a routine inspection, the inspection type may then switch to a “for cause” inspection.
Compliance Follow-Up Inspections review actions taken by a manufacturer in response to a previous inspection that resulted in significant 483 observations or a Warning Letter. A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action.
“For Cause” Inspections investigate a specific problem that has been reported to FDA by manufacturers, such as recalls, or by consumers or users through complaints. A “for cause” inspection focus on the reported issue but can branch out to cover unrelated elements of the firm’s operations. This inspection usually is initiated at the request of CDRH, CDER, ORA, or regional directive. These inspections typically are more in-depth than routine inspections.
If your company is expecting one of the FDA inspections listed here above, it should prepare for it seriously, because any serious finding, will withhold its new product’s approval or will have a negative impact on its commercialized products.
Global Regulatory Partners, Inc. Certified Quality Auditors have the skills and required experience to help pharmaceutical, biologic and medical companies prepare efficiently and in timely manner for all types of FDA inspections, so they can get their new products approved quickly and maintain the commercialization of their product without concern.
At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs.
GMP Mock-Ups Quality Audits
All manufacturers of Pharmaceutical, Biologics, Active Ingredients, and Cosmetic Products are required to implement and maintain their compliance with GMP requirements, to assure and demonstrated that their products are consistently produced to quality standards that are appropriate for their intended use.
Global Regulatory Partners Inc., (GRP) Certified GMP Quality Auditors have the skills and expertise to support companies assess, become and maintain their compliance with cGMP requirements as required by health authorities.
GRP Certified Quality GMP Auditors can perform CGMP “Mock -Ups GMP Audits” (GMP pre-audits that mimic health authorities GMP audits such as FDA, PMDA Japan, Health Canada, NMPA China or Anvisa Brazil inspections) according to 21 CFR 210, The mock -up audits help companies prepare for important health authorities inspections. GRP GMP auditor can perform internal audits as well to help companies assess their level of GMP compliance.
In general, GRP GMP Audits last 2 days per manufacturing site. They cover a full facility walk-through and manufacturing observation of all relevant systems, including the quality management system, organization and personnel, facilities and equipment, sanitation, production and process controls, warehousing and distribution, packaging and labeling and laboratory controls. They include quality and production documents and records review and verification, management and technician interviews.
After the completion of the GMP audit, GRP GMP auditor issues a detailed audit report that lists the audit’s findings and recommendation to address such findings as needed.
ISO 13485 Quality Audits
Audits performed at medical device companies several weeks prior their ISO 13485 certification by their notified body. As an outcome, GRP QA team makes sure that companies are aware of all their non-compliances so they can address them prior to the occurrence of the official ISO 13485 certification audits.
Sponsor conducting clinical trials on investigational medicinal products or devices, are required to show the planning, study conduct, performance, monitoring, auditing, analysis, and reporting all meet the ethical and scientific standards for Good Clinical Practice (GCP as outlined in ICH E6(R2) in 2016), otherwise the generated clinical data and results will be challenged by health authorities and may be not accepted and used for product‘s registration.
Global Regulatory Partners, Inc,. Certified GCP Auditors have the skills and required experience to help pharmaceutical, biologic and medical companies identify potential risks and help ensure compliance issues to avoid jeopardizing the clinical study.
GRP GCP auditors can perform full clinical trial audits over different clinical trial sites. GCP audits cover the following:
- CRO and other vendors qualification and selection process.
- Regulatory compliance for study integrity and essential document collection.
- Data management and electronic data capture (EDC) systems
- Electronic medical records (EMR) integrity
- Data integrity.
- Electronic Trial Master File (eTMF)
- Protocol, reports , and sponsor/CRO SOP compliance
- Audits of submission for ethical approval for clinical trials
- Study monitoring
- Investigators and personnel training and qualifications
- PI availability and oversight
- Adverse Event (AE) reporting, Informed Consent, safety and subject enrollment criteria
- Case Report Form and Source Data
Companies that manufacture Human cells and tissue-based products (HCT/Ps) used in replacement and regenerative therapies must comply with the requirements of Current Good Tissue Practices (cGTP) described in 21 CFR 1271.
Current good tissue practices (cGTPs) govern the methods used in, and the facilities used for, the manufacture of human cells, tissues, and cellular and tissue-based products (HCT/Ps). cGTPs focus on the prevention of the introduction, transmission, and spread of Communicable Diseases or other adverse events while preserving product function and integrity.
Human cells and tissue based products manufacturers are subject to frequent Food and Drug Administration (FDA) inspections, to assess their compliance with cGTP and Global Regulatory Partners, Inc. Certified GTP Auditors have the skills and required experience to help HCP/Ps manufacturers comply with cGTP and implement the appropriate measures to prevent their products from any potential risk of contamination with transmissible diseases during their collection, processing and distribution.
GAP Analysis Audits
GAP analysis Audits are often performed by companies that want to assess their level of compliance to required quality standards to be able to make the appropriate improvements.
Global Regulatory Partners, Inc, (GRP), Certified Quality Auditors have the skills and expertise to perform Gap Analysis Quality Audits of facilities and operations of pharmaceutical and medical device companies.
Gap Analysis Audits performed against defined quality standards and regulations, such as FDA QSR, FDA GMPISO13485, Japan PAL, EU regulations, and Canadian Standards CMDR. Gap analysis Audits are typically conducted before the implementation of a new quality management system, or before health authorities inspections. audit.
Foreign manufacture accreditation (FMA)
PMDA (Japanese Health Authorities) requires companies to pass and complete an accreditation audit prior to registration in Japan.
GRP- Japan can help pharmaceutical and biologic companies prepare for the Japanese accreditation audit.
QA SOPs development
Quality Standard Operating Procedures (QA SOPs) are written documents that provide instructions how to perform quality activities within an organization. The development, implementation, and maintenance of the appropriate QA SOPs are crucial for a successful quality management system. If not written correctly, individuals will not have the appropriate information and instructions how to perform properly their tasks and assume their responsibilities. Companies that do not have and follow the appropriate QA SOPs cannot demonstrate the quality of their products to health authorities.
Global Regulatory Partners Inc., (GRP) quality team has the skills and expertise to develop, implement and maintain the appropriate a tailored QA SOPs for your quality management system and organization.