In the pharmaceutical industry, all products must be approved by the local authorities of the countries where manufacturers will sell them. For pharmaceutical cannabis products, different countries in the European Union have disparate requirements.
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Michael Sassano & Antonio Guedelha:: GMP #18: Sales Planning for Pharmaceutical GMP Facilities
All startups, including new pharmaceutical manufacturing facilities, need to grapple with the complexities of launching. Pharmaceutical products are a considerable challenge and require a longer-term perspective. You will face more than regulatory hurdles associated with registering pharmaceutical products and will be challenged to coordinate a talented sales team with your production capacity. We will walk you through some ideas to help you plan sales efforts more efficiently.
Michael Sassano & Antonio Guedelha: GMP# 17: GMP Market Forecasting and Budget Management
GMP processes are slow and have an intense workload for documentation of new products that depend on the country regulators’ scheduling, further complicating release forecasting for medical products. Even more challenging are the rules for disjointed regulations, as there is a lack of uniformity across countries for new items like pharmaceutical cannabis products.
Michael Sassano & Antonio Guedelha: GMP # 16 – Waste Reduction Management in Good Manufacturing Practice
The pharmaceutical manufacturing industry is one of the largest waste producers in the world. In the past, manufacturers paid a third-party removal company to dispose of waste. In recent years, the strict regulations enacted on manufacturers have prompted many companies to seek more sustainable production processes. The world of pharmaceutical waste management is developing more robust standards and dedicated groups to concentrate on sustainability, and individual companies must keep up.
Michael Sassano & Antonio Guedelha: GMP #15 – Quality Control Laboratory Optimization in GMP
The management of a Pharmaceutical Quality Control Laboratory is a complex task that contributes to monitoring and supporting every part of your product’s quality. Although the primary functional aspects of the laboratory are sampling, sample preparation, analysis, documentation and investigations on the product manufacturing, the Quality Control (QC) area also manages safety, the entry and exit of persons and materials, behavior, material stock, reactants, and standards.
Michael Sassano & Antonio Guedelha: GMP #14 Client Management in GMP
Pharmaceutical cannabis companies with industrial manufacturing facilities operate in a global market and can cater to a broad range of potential clients. You can sell cannabis products to the Active Pharmaceutical Ingredient (API) markets, finished products can be white labeled, and branded finished products can be sold to pharmacies. You can also engage in contract manufacturing. The main differences between these options are whether you sell to pharmacies or other companies.
Michael Sassano & Antonio Guedelha: GMP #13: Preventive Maintenance in GMP
Consistent and reliable pharmaceutical manufacturing depends on many factors, but a critical one is the process equipment. If the process equipment is faulty, the product quality may be at risk, and downtime may be inevitable.
Michael Sassano & Antonio Guedelha: GMP #12: Optimizing Pharmaceutical Good Manufacturing Processes
Manufacturing process optimization aims to increase productivity, decrease operational costs, and make the manufacturing process more robust via a more stable, controlled analysis with fewer errors. We will concentrate on step-by-step improvements using the Plan, Do, Check, and Act (PDSA) methodology.
Michael Sassano & Antonio Guedelha: GMP #11: Stock Management in GMP Manufacturing
In Good Manufacturing Practice (GMP) facilities, managing your stock is critical for Quality Assurance (QA). Your QA team needs to track the raw materials, ensure their correct use, and know potential losses, actual losses, and the products near or exceeding the expiration date. For example, the cannabis industry’s average value of the stock of raw materials can reach 15 to 20% of the yearly value of the sales. This makes a stock management strategy a crucial global business management action. Expired products can cause losses, and there are also extra costs associated with the removal and destruction of expired products.
Michael Sassano & Antonio Guedelha: GMP Article 10: Production Cost Calculation Systems in GMP
When you look to the future of your company’s life cycle, financial health in planning your exact production costs will help inform important decisions pertaining to profitability. Much of this financial planning was developed in your ERP stages and general decision-making was covered in GMP #9. As time goes on, developing these individual models for production costs is a precise product-by-product series of equations. Additionally, each different GMP product facility has individual calculations of inputs and concerns.