We can perform many of the tasks that are part of the Quality Unit responsibilities. 

Standard Operating Procedures (SOP)

Most Quality Management Systems are weakened by lack of effective and well-written Standard Operating Procedures. In some cases, even when key SOPs exist, they miss the critical requirements, both from a regulatory and operational effectiveness aspects.

We have successfully helped several clients in establishing well-integrated Standard Operating Procedures that strengthen the Quality Management System, and reduce the cost of quality and compliance. Our SOPS are based on a standardized template and a highly readable and executable form. Our consultants, will do a walk-through of the procedures before developing them, so it will include key inputs from your user group. 

CAPA Program

An effective CAPA program will reduce your overall rate of discrepancies, and compliance failures. We have helped several clients in developing the overall Corrective and Preventive action program that is geared for reduction of discrepant events, human error, and QMS failures. Our consultants will work with you to establish key Quality Metrics, and integrate it with your Quality Assurance plans. This process is not a magic bullet, and it will take some time to implement, but once it is implemented and monitored, your organization will reap the benefits with reduced cost of Quality and establishment of a sustainable regulatory compliance program.

Quality & Compliance Assessments

Quality Unit is authorized and responsible for a wide-range of activities. FDA typically cites the weakness of a Quality Unit in their 483 and Warning Letters. 

We will use your internal SOPS and the most current regulatory standards to conduct assessments of your Quality Management System. We will risk rate your compliance and product quality exposure, and provide you with guidance to remediate the gaps. 

Suppler Audits

Supplier Management Programs often impose a high level of risk and resource burden for many of our clients. We can help by conducting audits and inspection for these key stakeholders of your Quality Management System. Our consultants will conduct a well-defined assessment of your supply-chain’s Quality Management system and provide you with a professional, risk-rated report. We will even help you with developing and implementing strategies for correcting the weakness of this program.

Data Integrity Assessment

Data Integrity is a very hot topic with the FDA, and rightly so. The requirements are so confusing, and the implementation of secure access and a confident Data Integrity prevention plan so complex. We can help. Our consultants, will conduct a thorough baseline assessment of your overall Quality Management System with regards to Data Integrity. We will even help you with developing and implementing strategies for remediating the breaches and addressing gaps that has already been identified.

Batch Record Reviews

One of our Quality Staff augmentation service includes a review of executed batch records, and Laboratory Reports. Our qualified staff thoroughly review your batch records according to a standardized template and criteria based on your own internal SOPS. We will highlight any errors, and its impact on the decision for product disposition.

Quality Metrics Program

An effective Quality Metrics Program is an inexpensive insurance and a key tool for your Senior Management. With the new guidance from the FDA on effect, very few companies have established a robust and effective Quality Metrics program that provides the right, actionable information at the right time.

Our consultants, can help you with reviewing and understanding all the key inputs and outputs for this very important program. We will create visual dashboards so that your entire organization is synced towards the common goals of achieving a robust Quality Management System, and a sustainable regulatory compliance program.

 To learn more and to get a free quote, please contact us today.

Phone: (267) 334 5722 | Email: [email protected]

Preparing for an FDA Inspection

Preparing for an FDA inspection is not a DIY project. While many companies have competent internal resources, the stress of an impending inspection causes many daily functions to suffer. We, at GMP Scientific, can make it easy for you by managing your overall inspection readiness plan with well-proven strategies, and support your organization with a detailed execution plan.

We do it all, from planning and developing detailed timelines, establishing milestones, identifying and reducing risks, communicating with your management, training and coaching your personnel, and augmenting your resources with qualified consultants.  

These planning and preparation exercises will strengthen your organizational confidence in facing the FDA inspection.

Responding to FDA 483 observations & Warning Letter

Responding to FDA 483 observations or a Warning Letter causes an extraordinary burden on a firm’s Quality System and organizational resources. We, at GMP Scientific, can provide you with expert guidance, in a timely professional manner that will enable you to meet FDA expectations. 

We do it all, from planning your response and remediation strategy to preparing a detailed execution plan, and support your overall project until you have an acceptance from the FDA. This will improve the overall confidence and improve your organizational competence in responding to the FDA.

To learn more and get a free quote on your needs, contact us today.

Phone: (267) 334 5722 | Email: [email protected]

Training that “sticks”

Many of our small and mid-size clients struggle with the development and implementation of an enterprise wide, effective learning and development program.

We understand. We will help develop an effective GMP and Technical training program that is integrated with your Quality Management System. Our training modules are customized based on our client needs, and include highly interactive sessions. We agree that a  powerpoint presentation or a video show does not guarantee employee understanding i.e the training will not ‘stick’.

Our training classes are based on Adult Learning Principles that are powered with active participation. We will also do an assessment before and after the training to demonstrate learning effectiveness. 

To learn more, download our current training brochure, and get a free quote.

Phone: (267) 334 5722 | Email: [email protected]

 

Training Brochure Content below

GMP Scientific, Inc. is pleased to offer training in the following areas.

Our training classes are based on adult learning principles and conducted by qualified and experienced industry professionals.

Each module will include

–    Learning Objectives

–    Interactive exercises

–    Knowledge assessments

–    Effectiveness checks

–    Ongoing support

– Online access to content

Module 101 –  GMP Fundamentals –  4-hour class

–    The Big Picture – Patient Safety

–    History of FDA Regulations

–    A business case for compliance

–    Review of 21 CFR 210 & 211 (Drugs) Each subpart will be reviewed

–    Your roles and responsibilities

Module 102 – Science & Compliance – 60-90 Minute Modules

–    Introduction to Modern GMPs

–    Six System Approach

–    Management Role

–    Integrating scientific principles for sustainable compliance

–    Quality Risk Management

–    Modern Concepts – Process Analytical Technology (PAT), QbD

–    Six-Sigma, Lean and Process Capability Studies

Module 103 – Discrepancies, Deviations, Out of specifications – 1- 3 Day classes

–    Regulatory Requirements for handling discrepancies

–    Introduction to FDA Guidance Documents

–    Conducting Effective Investigations

–    Field Alerts

–    Workshop (additional Day)

Module 104 – Records & Reports (Data Integrity/Data Reliability) – 1 Day class

–    Current trends in Data Integrity – What is your exposure?

–    Review current guidance on Data Integrity

–    Computer Systems & 21 CFR Part 11 guidance

–    Review current FDA 483 & Warning Letters

Module 105 – Contamination Control – Principles & Practices (Non-sterile products) – 4-hour class

–       Types of contamination – physical, chemical, microbial

–       Personnel Hygiene/Practices

–    Gowning & Personal Protective equipment/PPE

–    Material, process and personnel flow

–    Storage & Handling

–    Environmental control

–    Environmental Monitoring

–    Cleaning & Sanitization

–    Sampling and testing

Module 106 – Self Inspections/Internal Quality/Compliance Audits and Assessments – 2-hour class

–    Regulatory Expectations on Self Inspections/Assessments

–    Planning an audit (Get ready kit)

–    Executing

–    Closing

–    Training & Qualification Requirements

–    Time Management

–    Best Practices (Do’s & Don’ts)

Module 107 – Supplier Quality Management – 4-hour class

–    Regulatory Requirements on Supply Chain Excellence

–    Supplier Contract Management

–    Qualification & Disqualification criteria

–    Quality Agreement

–    Supplier Audits

–    Quality Metrics (Supplier)

Module 108 – Quality Management System –  4-hour class

–       Management Controls

–       Quality Metrics

–       Quality Council/Management Reviews

–       Quality Manual/Quality Manual/SOP Structure

Module 109 – Regulatory Affairs – Best Practices (Each module is approximately 45 – 90 Minutes)

–       Introduction to FDA’s Regulatory Framework

–       Introduction to FDA Guidance Documents

–       Regulatory Inspection Management

–       Communications with the FDA

–       Writing and responding to the FDA

–       Telephone conference with the FDA

–       In-person visits with the FDA

–       Managing Regulatory Changes & Supplements

–       Complaint Systems/Adverse Event Management

–       Good Documentation Practices

–       QbD – Quality By Design

–       Annual Product Reviews

–       Field Alerts

–       Annual Reporting

–       Drug Product Recalls & Product Withdrawal

System Specific Training Modules

Module 201 – Quality Assurance (2-Day class)

–       Roles & Responsibilities

–       Sampling & Inspecting

–       Line Clearance

–       Batch Record Reviews

–       Handling Deviations

–       Corrective & Preventive Action Program

–       Complaint Management

–       Change Control Management

–       Documentation Control

–       Internal Audits

Module 202 (A) – Laboratory Controls – Quality Control – Chemistry & Physical Laboratory – Customized per client needs assessments

Good Laboratory Practices

Managing Workspace

Standards and Reagent

Sampling & Testing

–       Equipment set-up, cleaning, maintenance, calibration

–       Laboratory Records Management (Forms/Logbooks

–       Laboratory Computer System (21 CFR Part 11)

–       Data Integrity for Laboratory/Electronic Data/Applications

–       Handling Laboratory OOS and OOT

–       Quality Metrics – QC Laboratory

–       Methods Validation

–       Stability Program Management

–       Reduced Testing Program

Module 202 (B) – Laboratory Controls – Microbiology – Customized per client needs assessments

–       Contamination Control

–       Workspace Management

–       Aseptic Techniques

–       Microbial Growth Media/Preparation, sterilization, growth promotion)

–       Stock Culture Management

–       Microbial Sampling (Laboratory)

–       Microbial Sampling (water system, environmental, product)

–       Sterility Tests

–       Laboratory Cleaning & Sanitization

–       Equipment

–       Autoclave

–       ETO Sterilizers

–       Sterilizing Ovens

–       Incubators

–       Refrigerators

–       Particulate Samplers

–       Gowning & Personal Hygiene

–       Reporting Discrepancies & Deviations

Module 203 – Production & Process Controls – Customized per client needs assessments

–       Line Clearance & Set-up

–       Production and Process Controls

–       Good Housekeeping, Cleaning and Sanitization

–       Environmental Control & Monitoring

–       Executing Batch Records

–       Raising Discrepancy reports

–       Change Controls

–       Good Documentation Practices for Production Personnel

–       Understanding QA Roles & Responsibilities

Module 204 – Facilities & Equipment – Customized per client needs assessments

–       GMP Requirements

–       Facilities Design

–       Environmental Control, Monitoring, Site Mapping

–       Building Management Systems

–       Access Control

–       Storage & Handling

–       Cleaning, Sanitization, Contamination Control, Pest Control

Module 205 – Packaging & Labeling Controls – Customized per client needs assessments

–       GMP Requirements

–       Label Control (Revisions)

–       Control of components, closures, drug product packaging & labeling

–       Serialization (new requirements)

–       Line Clearance

–       Executing Packaging Batch Records

–       Raising Discrepancy reports

–       Rework and re-dress of packaged product

–       Reconciliations

Module 206 – Warehouse & Distribution – Customized per client needs assessments

–       Warehousing (Manual and Automated storage/retrieval systems

–       Storage and handling

–       Environmental Control and Monitoring

–       Contamination Control

–       Managing spills

Module 207 – Material System – Customized per client needs assessments

–       Receipt and handling

–       Sampling and storage

–       Contamination Control Practices

–       Approval/Rejections/Quarantine

–       Material usage and reconciliations

–       Use of Inventory Management Systems

–       Salvaging and Destruction

Module 301 Aseptic Processes – 2 Day class

– Guidance Review

– Assessment for Aseptic Facilities

– Fundamentals of Microbiology

– Gowning and Sanitary Practices and qualifications

– Clean Room Behavior

– Media Fill Program

– Cleaning and Sanitization

– Environmental Control and Monitoring

– FDA Guidance

– ISO 14644

Process Validation and Process Capability Projects

Process Validation and Process Capability are more than just regulatory requirements. A validated and capable process demonstrates that it will continue to produce medicinal products that meet the specifications. Secondly, it reduces the overall cost of quality by minimizing wastes due to rejections, and preventing process discrepancies that need to be investigated.

We can help you adequately characterize the process and develop a well defined process validation strategy. Secondly, we can also help improve process controls to further reduce statistical variability. 

Lean and Six-Sigma Projects

Lean and Six-Sigma projects are often implemented with little thought to regulatory requirements of planned redundancies and purposeful oversight by the Quality Control Unit, over manufacturing and related activities.

When implemented correctly, however, Lean, and six-sigma project can be well-aligned with the regulatory oversight requirements. We, at GMP Scientific, can help you evaluate all the critical inputs and outputs of the DMAIC process and provide you with appropriate guidance to align your oversight steps.

 To learn more and to get a free quote, please contact us today.

Phone: (267) 334 5722 | Email: [email protected]