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cGMP: Introduction to Good Manufacturing Practice (GMP)

cGMP: Introduction to Good Manufacturing Practice (GMP) Certification Training

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(22 reviews)

Program/Course ID:GMP01
Enrollment Period:12 months.
Average Learning Time:~60 minutes.
Additional Resources:Supplemental materials/activities.
Credit Hours:2 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Good Manufacturing Practice (cGMP).
Demonstration:Four (4) free trial courses are available.
Group/Employee Training:Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training Program: cGMP: Introduction to Good Manufacturing Practice (GMP)
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Biopharma Institute Reviews

This cGMP: Introduction to Good Manufacturing Practice (GMP) course includes sections on:

  • Introduction to current good manufacturing practices (cGMPs)
  • Maintaining product quality
  • Scope of GMP rules
  • Cleaning and sanitation
  • Proper documentation
  • Summary.

The course explores a list of essential packaging and production controls, reviews guidelines detailing the proper way to execute GMP records, describes GMP personal hygiene requirements, clarifies the four key product quality attributes, explains the purpose of GMP codes and regulations, and offers explanations of why companies are required to follow GMP guidelines, and the consequences if they do not.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


- What is GMP?
- Objectives
- Reviews and assessment
- Events that have shaped GMP
- Evolution of GMP
- Introduction to GMP codes
- GMP regulatory bodies (EMA, FDA, Health Canada, Medsafe, MHRA, PIC/S, TGA, WHO)
- Specific GMPs (FDA, EU, PIC/S)
- What is GxP?
- Why are GMPs important? Select all that apply.
- GMP stands for?
- Match the GMP regulatory body to the region Quality
- What do you think?
- What do the GMP rules state?
- What is product quality?
- Purity
- Identity
- Effectiveness
- Safety
- Why does quality matter?
- Pharmaceutical Quality System (PQS)
- Select true or false for each statement
- Fill in the blanks

Scope of GMP rules
- What do you think?
- What do the GMP rules state?
- Scope by EU and PIC/S Guide to GMP chapters
- Comparing GMPs of the EU and PIC/S with the FDA
- Personnel and training
- Premises
- Equipment
- Manufacturing areas
- Manufacturing controls
- Self inspection / internal audit
- How much is true?
- What's the impact?
- Why are self inspections needed?

Cleaning, hygiene and gowning
- What do you think?
- What do the GMP rules state?
- Housekeeping
- Cleaning and sanitation
- Personal hygiene and gowning
- Topic review

- What do you think?
- What do the GMP rules state?
- Proof of product quality
- Manufacturing records
- Rules for completing records
- Which correction is correct?
- Electronic data
- Data integrity
- True or false?
- Select all that apply

- Summary


This module provides a solid introduction to control and management of manufacturing and quality of pharmaceutical products.

- Explain why your company has implemented GMP
- State the purpose of GMP regulations
- State the four key product quality attributes
- State the requirements for personal hygiene
- Describe the correct way to complete records
- List the essential production and packaging controls

This Course is Included in the Following Professional Certification Program(s):

Professional Certification Program:

Current Good Manufacturing Practice (cGMP) Professional Certification Program

Program ID: GMP001S1
Price: $1795.00 (USD)

Professional Certification Program:

US Pharmaceutical Quality Assurance (QA) Management Professional Certification Program

Program ID: QAPRO
Price: $1895.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.