Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online, Asynchronous, Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $195.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: cGMP: Good Manufacturing Practice in Packaging Medicinal Products
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
Packaging operations constitute the last manufacturing step before release of a product to the market. They convert bulk product to the final product.
Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. In this module we describe the functions that packaging must fulfill and the quality controls that are applied to packaging materials and operations. We set out the requirements for control of printed materials. We describe preparation, in-process control, and completion of a packaging run. Finally, we explain how to carry out reconciliation of packaging materials.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
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.
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 instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
An outline of the module's scope and objectives, and notes on terminology.
Packaging, or container-closure, systems must contain and protect the product from spoilage, preserve its stability, and provide evidence of tampering as required. Labeling must provide the correct information about the product, its storage requirements, and its use. Information that allows the distribution of batches to be traced should be included, and measures to defeat counterfeiters are increasingly required. Packaging quality affects product quality, so packaging materials, systems, and operations are subject to quality assurance requirements that are similar to those for starting materials and products. Controls must be in place to provide assurance that packaging fulfills its various functions. In this session we set out those functions and sketch examples of the kinds of controls that are necessary.
Control of printed materials
Control of printed materials is an especially important part of packaging operations. All information on packaging materials and inserts must correctly apply to the product and batch. Mislabeling/mis-branding of a drug is a very serious error. In this session we describe controls applied to printed materials at the printer, on receipt of inward goods, and in storage, issue, and return to store. We outline how variable data such as batch numbers and expiry dates can be coded on packaging materials. Finally, we emphasize the importance of reconciliation of printed materials.
The packaging run
A packaging run is subject to controls similar to those for the processing of product. Checks must be carried out beforehand, in-process and other quality controls need to be applied during the run, all operations must be recorded, and cleaning needs to be done afterwards. In this session we identify documents that need to be followed for the run, we describe line clearance and set-up tasks, and we discuss in-process controls and statistical quality control.
Reconciliation of materials
Reconciliation of materials is an important control for packaging operations. In this session we describe the reconciliation of quantities of product and of printed matter.
Multiple-choice mastery assessment.
Who will benefit from this module
This module provides essential training for all personnel who work on the packaging of medicinal products. Other staff working in a manufacturing environment in the pharma/biotech industry will also benefit from this module. This is a great GMP refresher training program for those working in a GMP environment.
- Describe the functions of packaging and give examples of controls applied to packaging materials and operations to provide assurance of quality
- Specify requirements for control of printed materials
- Adopt good practice in the preparation, in-process control, and completion of a packaging run
- Explain how to carry out reconciliation of packaging materials
cGMP: Good Manufacturing Practice in Packaging Medicinal Products is included in the following professional certification programs:
Price: $995.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They 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 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: 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.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- Purchase orders (POs): If issuing a PO is required by your company, request an invoice to start the procurement process.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.