GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products.
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There are several guidelines for good manufacturing practices worldwide like WHO , FDA and EU. These guidelines have recommendations for almost all departments of pharmaceutical companies like manufacturing, quality control, storage and distribution.
Components of GMP (Good Manufacturing Practices) includes:
1. Personnel
Personnel working in the manufacturing and quality control should be properly trained and qualified for work they are responsible. Their jobs and responsibilities should be documented and training of their respective role must be documented.
2. Facilities and Equipment
Facilities and equipment must meet the GMP requirements for pharmaceuticals. Facility must support to protect the product from contamination and should be clean. Facility must have suitable manufacturing area, storage area and utilities like water system, HVAC system and cleanrooms. Equipment installed in manufacturing area must be qualified, installed and maintained.
3. Materials
In a GMP facility, there is a strict control over the raw material and other components used in manufacturing. There should be a well-defined procedure for receipt, sampling and storage to ensure the quality, identification and use of the manufacturing components. There should be proper control during handling and storage of raw material to prevent it from contamination and mix-ups.
4. Manufacturing Process
There must be a well-defined and controlled manufacturing process. Manufacturing process should be validated . Out of specification results and deviations must be investigated and addressed appropriately.
5. Sanitation and Hygiene
According to GMP it is essential to maintain a clean and hygienic manufacturing area for drug products. This component of GMP includes the regular cleaning and sanitization of the facility and equipment, a well-defined waste disposal procedure and implementation of personal hygiene practices.
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Two more essential comonents of GMP
Documentation and Record Keeping
Accurate and complete documentation is essential in pharmaceuticals. It is a critical component of the good manufacturing practices. It is required to follow the ALCOA principles which includes control of various documents like batch manufacturing records, SOPs, specifications, protocols and reports. All data related to raw material, manufacturing process and quality control should be properly recorded and retained.
Quality Management System (QMS)
It is essential to establish a strong quality management system to control the processes, procedures and responsibilities to ensure the production of quality products by handling documentation, change control, deviation and other quality related incidents in properly controlled manner.
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Many pharmaceuticals companies operate as start-ups until they secure funding or FDA-approval of their products. Initially, QuickBooks and other entry-level mid-market solutions are sufficient to manage finance operations and inventory but once customer orders are accepted and production begins, the gap between the company’s needs and QuickBooks functionality starts to widen dramatically. That gap is often filled by excel documents and manual ad-hoc processes, leaving room for potentially dangerous errors. [Sound like your company? Read our blog on Pharmaceutical Inventory management for key red flags] Savvy CFOs soon realize that a solution tailored specifically to the pharmaceutical industry is imperative to scale effectively.
Here are the six most common, required functions for growing pharmaceutical companies that traditional discrete manufacturing solutions do not provide.
1. Contract Manufacturing
It’s common among pharmaceutical companies to outsource the manufacturing processes to a trusted contract manufacturer. This allows the organization to focus on innovation, sales, and performance while investment in equipment and the manufacturing is completed elsewhere. Contract Manufacturing functionality allows the company to define the formulations and routing instructions, secure the procurement of raw materials from trusted vendors, relieve vendor managed inventory, and recognize the costs of production without performing the actual activities in-house. Most importantly, traditional discrete manufacturing solutions do not properly account for revenue and cost recognition regulated under percentage-of-completion methods (PCM).
2. Inventory Management
Pharmaceutical companies require inventory with product features such as active ingredients, stock managed by potency, average potency percentage, expiry, use-by-date coefficients, lot control, serialization, and other regulatory compliance requirements.
An ERP that delivers out-of-box item attributes and business processing logic dependencies for the pharmaceutical industry reduces the need for customizations. Customizing a solution that isn’t designed for pharmaceuticals intensifies the project scope and go-live risk resulting in increasing costs, lengthened project duration, and ongoing costs of maintenance with future releases.
3. Quality Control for Regulatory Compliance
Defining, capturing, and reporting Quality Assurance (QA) and Quality Control (QC) data is critical for pharmaceutical organizations with strict tolerance of raw materials, storage and handling, formulations, and finished products. Quality data should be integrated and associated with each touchpoint throughout the product lifecycle for on-demand status inquiries and reporting. Thorough and extensible functionality in the QA/QC space will include safeguards to protect from undesirable outcomes like quarantining, non-conformance, and safe disposal.
4. Formulation Management with Dynamic Batch Sizing
Traditional manufacturing solutions are programmed to track products and components that can be assembled or disassembled discretely. Process manufacturing methods rely on complex formula optimization with variables that include chemical properties, reactions, variants, dynamic batch sizes, yields, and ‘sandboxes’ for R&D.
5. Traceability and Recall Management
Unfortunately, mistakes happen and sometimes product recall is necessary for product integrity, company reputation, and consumer safety. In the event of a recall, coordination with regulatory agencies and proactive communication is vital to resolution. Audit controls and reporting that can generate parent-child relationships through forward-backward traceability provide transactional data and assurance that the company adheres to current good manufacturing practices (CGMP).
6. Automated Intercompany Purchases, Sales and Elimination Entries
Another common best practice for growing pharmaceutical companies is to establish independent entities for overseas facilities and international sites. Multiple company scenarios are required to meet the unique in-country regulatory requirements and accounting localization standards for distribution, taxation and reporting. A system that supports automated intercompany transactions and elimination entries streamlines the accounting practice to ensure proper currency exchanges, cost absorption and revenue recognition. Automated entries create an audit trail for transactional integrity and help reduce period-end close adjustments from mistakes or omissions.
Conclusion
If you suspect your growing company could be falling into a widening technology gap, start by running an audit of your organizations software and processes. Once you identify the shortcomings of your existing solution and their impact on business, you’ll be able to outline your upgrade project based on the urgency of your need and begin investigating alternative software solutions.
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