A personalized strategy for each goals
The process of pharmaceutical development includes multiple steps required to bring a pharmaceutical drug product to the market after the molecule has been synthesized. Product development programs at All Pharma, LLC. are established in facilities and with equipment assuring the highest level of production quality. All systems are cGMP compliant. Projects are scaled according to capacity requirements from low-volume to high-volume production.
Excipient Compatibility tests evaluate interactions between the drug and components in the pharmaceutical formulation. For solutions and suspensions, results help determine buffer selection and measure the optimum pH level.
Process Development and Optimization
Process development and optimization services are designed to maximize efficiencies in the manufacturing process resulting in reduced cost and increased productivity.
Well-designed tests conducted from the beginning of the formulation stage may help contain costs and increase efficiency during the manufacturing phase. Testing is established to evaluate equipment optimization, operating procedures and control mechanisms. The All Pharma, LLC. team critically examines whether equipment utility is maximized, how output varies between people or operating shifts and if procedures and practices function as designed.
Cleaning Validation procedures are designed to assure that residues are removed from equipment and that cleaning supplies are suitable and appropriate for their purpose.
Analytical Method Development and Validation
Analytical method development services and validation are required by regulatory authorities to demonstrate that testing during the development process is appropriate for the intended use of the drug product. Pharmaceutical analytical services establish the identity, purity, physical characteristics and potency of the drug formulation. The range of pharmaceutical laboratory testing and subsequent results analysis involves collaboration between the All Pharma, LLC. Quality Control department and the Research and Development Analytical team.
Results of analytical method development tests assess prototype formulations, determine product stability, discover batch-to-batch variability, verify USP methods and enable transfer of analytical procedures.
The correctness of the scientific method used to conduct studies and tests is known as validation. The development of any pharmaceutical drug product relies on precise scientific methods to confirm the correct substance appears in the correct amount and in the appropriate range for the intended purpose. All Pharma, LLC. follows written standard operating procedures (SOP) describing each process for conducting method validation. Instruments are carefully calibrated and test methods are conducted according to an approved protocol plan.
Scale-up determines best practices to increase production for sales and distribution requirements.
Increasing manufacturing output to achieve production quantities requires a skillful combination of experience, science and engineering. The process involves three important considerations: pre-production issues, concerns during production and post-production circumstances. Acquiring an adequate supply of the API and all raw materials must be assured in advance for successful scale-up. Each step in the production process must be evaluated to avoid issues when changing from small-batch to full production quantities. Data is collected from small-scale production runs that may yield important information that streamlines full-scale production methods. As each successive batch is manufactured, process ranges are identified that are documented according to an approved protocol written in advance of full-scale production. Scale-up procedures must adhere to strict regulatory requirements. The Scale-Up And Post-Approval Changes (SUPAC) guidelines are set by the FDA to determine whether changes are needed to the established manufacturing process. Prescription New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) filings must also be submitted for government approval.
The efficient transition of technical and manufacturing capabilities between separate entities is known as technology transfer.
Whenever technology or production is shifted from one entity to All Pharma, LLC. , a transition team with specialized experience evaluates all capabilities from raw materials through production to assure a successful outcome. A comprehensive check-list is completed to help ensure client satisfaction.
The team examines original formulations, production methods and equipment that may require modification to machinery and procedures within the All Pharma’s facility. Additional training may be required. Documentation must be complete including up-to-date production records and SOP protocols concerning processing, packaging and cleaning. At times, assistance from the previous manufacturer is sought if available to reduce cost and acquire insights helpful in the production process. All Pharma, LLC. submits regulatory filings confirming the required expertise and capabilities to complete the transfer. Packaging line trials and a health and safety review are conducted.
Technology transfer involves a dedicated All Pharma’s team committed to eliminating potential problems that may arise at the point of origin with the goal of establishing a timely, safe and effective program for starting or continuing production of pharmaceutical drug products at All Pharma, LLC.
Pharmaceutical Drug Manufacturing
Pharmaceutical drug manufacturing involves much more than producing product in the desired quantities. At All Pharma, LLC. , quality and care are two virtual ingredients added to every formulation.
We specialize in non-sterile oral solutions, liquid solutions, suspensions and semi-solids. Our knowledge helps clients contain costs which helps maintain a competitive advantage. Flexibility is built into our facility enabling batch sizes in small or large quantities. Procedures follow cGMP guidelines for development, testing, manufacturing and packaging. Manufacturing suites include segregation and engineering controls.
The All Pharma, LLC. team applies extensive expertise in pharmaceutical manufacturing to assure timely production according to client specifications resulting in high quality product distributed on schedule to meet the needs of patients.
Variable Batch Sizes
Need more or less? All Pharma, LLC. is able to modify production batch sizes according to client instruction and market demand. Establishing batch size is an important element in pharmaceutical manufacturing. Guidance about optimal batch size is provided by the FDA’s cGMP guidance. Several factors affect minimum batch size including API percentage in the formulation and the selected manufacturing process. … assists with the documentation and filing requirements to modify batch sizes that enables production to continue on schedule.
All Pharma, LLC. applies cGMP guidelines to assure drug products are manufactured that meet all attributes they are intended to possess. Effective process validation involves analysis of data collected through testing phases leading to high product consistency and quality during manufacturing.
Cleaning validation procedures are designed to assure that residues are removed from equipment and that cleaning supplies are suitable and appropriate for their purpose. Proper cleaning validation minimizes the potential for cross-contamination. Before designing cleaning procedures, All Pharma, LLC. determines all physical and chemical characteristics of the product ingredients.
The Quality Assurance team at All Pharma, LLC. is trained to monitor all aspects of the development, manufacturing and distribution processes that affect drug product quality. The QA team often recognizes quality issues and corrects them before they affect the final product.
Sampling, specifications and testing are the authority of the Quality Control (QC) department. Raw materials are not authorized for use until all necessary tests are conducted and results analyzed according to cGMP guidelines. When the QC department is assured of appropriate product quality, materials are released for manufacture and distribution.
Drug safety is a primary focus of the All Pharma, LLC. Microbiology Lab. Microbial contaminants affect the purity of pharmaceutical drug products. The Microbiology Lab at All Pharma conducts a variety of tests designed to detect micro-organisms in water and other drug manufacturing components. Effective microbiological testing ensures the finished product is sterile.
All Pharma, LLC. specializes in a variety of primary and secondary packaging for Over-The-Counter, prescription and specialty products including cosmetics, nutritional supplements and medical foods. Modern packaging lines accommodate plastic and glass bottles and jars, nasal spray devices, metal and laminate tubes. Secondary packaging and re-labeling equipment processes cartons, shrink-wrapping and shrink sleeves.
Equipment at All Pharma, LLC. is supplied with gravity-fed lines with no mechanical intervention. Stainless steel piping throughout the facility upholds cleanliness regulations and resist corrosion. Each project is treated with special handling that may include manual, semi-automated or fully-automated filling. Tamper-evident applications increase patient and family safety. Packaging and labeling capabilities include unique requirements for clinical trial shipments.
Packaging and Labeling Development
Packaging and labeling is critical to the authorized and successful commercialization of pharmaceutical drug products. Effective packaging and labeling helps to ensure customer safety, avoid product delays, recalls and enforcement actions. During the development stage, evidence is presented showing the final packaging configuration adequately protects the drug. All Pharma, LLC. packaging technicians work with each client to develop appropriate packaging options that meet cGMP guidelines. Strict labeling requirements are vital to patient safety. Labels must be informative and accurate and must also be updated when new information is obtained that is pertinent to the patient health. Safe, effective and approved packaging and labeling developed with All Pharma, LLC. maintain the integrity of the product as it moves within the pharmaceutical supply chain.
The Drug Supply Chain Security Act (DSCSA) is a set of Federal regulations administered by the FDA to identify and trace certain prescription drugs distributed in the United States in order to increase patient safety, minimize diversion and reduce counterfeiting. The FDA set a November 2018 deadline for companies to meet DSCSA regulations. All Pharma, LLC. is in compliance with current DSCSA requirements. After the deadline passes, brand owners will be held responsible to ensure their products are handled by DSCSA-compliant companies within their pharmaceutical supply chain.