|Program/Course ID: CGMP06|
Enrollment Period: 3 months.
Allocated Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
PRICE: USD $195.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: GMP: Good Manufacturing Practice in Packaging Medicinal Products
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access 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 program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.
Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.
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.
- 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
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on 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.
- Purchase orders (POs) accepted: If 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.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.