New Product Development Purpose:
New Product Development, To detail the standard operating procedure for the manufacturing of new products by Product Development Department.
New Product Development Scope:
This SOP is applicable for new product of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]Preformulation: Preformulation is the basic study of the physical and chemical properties of the product prior to start the formulation procedure. Generally, preformulation are conducted to get necessary information to optimize formulation of the products.
[][]Trial Batch: Trial batches are the batches that are conducted in small scale to finalize the formulation of the product in terms of physical feasibility and cost effectively.
[][]Batch: Batches are the Batch that will be prepared to conduct the full physical and chemical stability of the product.
[][]Development Batch: Development batches are the batches that are manufactured and packed using production machinery, for which full physical and chemical accelerated stability will be conducted. The batch size for Development batch should be at a minimum of one tenth of the commercial batch.
[][]Stability Study: Studies conducted to ensure that finished dosage form with excipient will exert to produce its intended effects over the shelf life.
[][]SAF: Sample Advice Form
[][]PB: Pilot Batch
[][]PV: Process Validation
[][]PD: Product Development
[][]DB: Development batch
[][]BMR : Batch manufacturing Record
Responsibilities:
The roles and responsibility are as follows:
Executive/ Sr. Executive PMD
[][]Issue of Product Proposal, Product Brief, Technical Feasibility Analysis Report.
Executive/ Sr. Executive Product Development
[][]Development of new products following this SOP.
[][]Preparation and periodic revision of the SOP
[][]To ensure that the documents technically are accurate and reflects the required working practice
Manager, Supply Chain Management
[][]To ensure availability of all necessary raw materials (active and excipients) for new product purpose
Executive/ Sr. Executive, Quality Control
[][]Analysis of samples of raw materials, trial batches, batches, Development batches, process validation batches.
Manager, Regulatory Affairs
[][]To provide all necessary information on regulatory requirements for new products.
Head of Quality Assurance
[][]Approve the SOP against XX Pharmaceuticals Ltd. master documents and current regulatory requirements.
[][]Ensure effective implementation of the SOP
Procedure:
[][]After getting Product Proposal, Product brief and Feasibility study report from PMD, start information collection about that product from all possible sources; i.e. BP, USP, BNF, Physicians’ Desk Reference (PDR), The Electronic Medicines Compendium, Mark Index, Martindale, Patent manufacturer of the API, Internet etc.
[][]Summarize or highlight that information vital for formulation in the preformulation Study (Annexure-I) & discuss with the members of team through a meeting, if required.
[][]Inform Quality control department to collect sample of the specific product, mention any specific requirement of the product and sample quantity through mail.
[][]Collect the sample of the product from market, preferably from patent manufacturer or of leading Brand Company. Check the physical parameters of the market products to set specifications of our final product.
[][]To get preliminary idea about formulation, make trial of minimum units of each dosage form and record on the Trial Batch (TB) Manufacturing Sheet (Annexure-II). Send the trial batch for QC analysis and figure out best probable formulation.
[][]Based on the information collected in preformulation study and considering trial batch formulation confirm product formula and issue manufacturing instruction for batches (DB). Total manufacturing procedure of batches should be noted properly in to the batch manufacturing record (Annexure – III)
[][] Submit the sample for analysis & compare the results with set specification previously set by the quality control department.
[][]After getting satisfactory results send the batch (DB) sample to production department along with ERP generated packing material requisition for primary packing.
[][] Store the finally packed samples in the accelerated and long term condition according to SOP/PD/003/02 & store the batch manufacturing record in to the product master file. It should be insured that for comparative study, market leading brands, preferably of patent manufacturer is being studied simultaneously.
[][] Analyze and evaluate the stability study results periodically submitted by Quality Control department. Discuss with the head of the department for further proceeding.
[][] After getting satisfactory batch (DB) results, take necessary action for scaling up in to Development batch (PB). Manufacture the Development batch according to the manufacturing formula and instruction of the batch, maintaining all GMP requirements for commercialization of the batch.
[][]Batch size of Development batch should be preferably equivalent to commercial batches and optimization of machine capacity should be considered properly.
[][]Total manufacturing procedure for Development batch should be noted in the Optimization batch manufacturing record (Annexure V), Critical process parameters be justifies and optimized for validation.
[][] For solid oral dosage forms the Development batch size is generally taken to be, at a minimum one tenth that of full commercial batch, or 100000 tablets or capsules whichever is larger, This quantity can be compromised only in case of machine capacity constrain.
[][] Check the analytical results in each & every steps of Development batch. Ensure that the results are within specifications. Then proceed to next step.
[][] Submit the sample of Development batch (PB) to QC laboratory for analysis and stability study following the same procedure as like batch (DB).
[][] To standardize the commercial batch size and to set all the process parameters, first Development batch will be manufactured as optimization batch under the direct supervision of concerned PD Executive. If more than three optimization batches are required for setting all process parameters then it should be justified through risk assessment.
[][] Satisfactory Development batch (PB) result should be informed to all concerned departments to pack as commercial batch according to launching forecast.
[][] Prepare Batch Manufacturing Record (BMR) for a particular product, based on the manufacturing record of Development batches. Finally hand over all related documents of a new product e.g. BMR, Batch formula etc. to Quality Compliance departments for start up the Process validation activities.
[][] On the basis of the approved BMR, next three consecutive commercial batches will be considered as process validation batches.
Reformulation Procedure
[][]A product will be reformulated for any or all of the following causes.
[][]A failure in the evaluation of validation program.
[][]In case of a deviation of a specification that cannot be trouble shoot.
[][]For changing the manufacturing process.
[][]A root cause analysis will be done by the Quality Compliance Department in case of the deviations.
Annexure:
Annexure – I: Preformulation Study Sheet.
Annexure – II: Trial Batch Manufacturing Sheet.
Annexure – III: Batch Manufacturing Record.
Annexure – IV: Optimization batch Manufacturing Record.