0.BSIC GMP

Good Manufacturing Practices (GMP): 

Good Manufacturing Practices (GMP) Presented by: Nishiprakash Jain

GENERAL DEFINATION: 

GENERAL DEFINATION Good Manufacturing Practice or GMP is a term that is recognized worldwide for the control and management of manufacturing and quality control of foods , pharmaceutical products, and medical devices . GMP's are guidelines that outline the aspects of production that would affect the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP Guidelines that correspond with their legislation .

GENERAL GUIDELINES: 

GENERAL GUIDELINES Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. Instructions and procedures are written in clear and unambiguous language; Operators are trained to carry out and document procedures; Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented; CONT…

PowerPoint Presentation: 

Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form; The distribution of the drugs minimizes any risk to their quality; A system is available for recalling any batch of drug from sale or supply; Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

Versions of GMP Guidelines : 

Versions of GMP Guidelines cGMP 21 CFR Parts 210 and 211 – Current Good anufacturing, Processing, Packing or Holding of Drugs; General and Current Good Manufacturing Practice For Finished Pharmaceuticals WHO GMP EU-GMP GMP as per ICH SCHEDULE M Similar GMPs are used in other countries, with Australia , Canada , Japan , Singapore and others countries.

Why GMP is important: 

Why GMP is important A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect. unexpected contamination of products, causing damage to health or even death. incorrect labels on containers, which could mean that patients receive the wrong medicine. insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

INDIAN PERSPECTIVE FOR GMP: 

INDIAN PERSPECTIVE FOR GMP GMP helps boost pharmaceutical export opportunities ( Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP ) Governments seeking to promote export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements India's pharmaceutical market currently stands ninth in the world market for pharmaceuticals with a 1.5% share . Current demand in the Indian pharmaceutical sector stands at about $4 to $5 billion, and is forecast to increase at an annual rate of 15 - 20% in the future. Hence GMP plays an important role to achieve this growth.

GMP Covers…: 

GMP Covers… ALL aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

QA, GMP & QC inter-relationship: 

QA, GMP & QC inter-relationship It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use QA

QC: 

QC Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality

GMP: 

GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use

QC and QA: 

QC and QA QC is that part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation,and release procedures which ensure that the necessary and relevant tests are carried out. ============================================= QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use

QC and QA: 

QC and QA Operational laboratory techniques and activities used to fulfill the requirement of Quality QC is lab based ================================= All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality QA is company based

Ten Principles of GMP: 

Ten Principles of GMP Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits

Cost of effective GMP: 

Cost of effective GMP In fact Cost benefits – positive cost benefits of GMP/QA Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices Reduction in work in process and inventory holding costs Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation)

List of important documents in GMP: 

List of important documents in GMP Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records

10 attributes of a good document: 

10 attributes of a good document Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized

Differing factors in various GMPs: 

Differing factors in various GMPs At a high level, GMPs of various nations are very similar; most require things like: Equipment and facilities being properly designed, maintained, and cleaned Standard Operating Procedures (SOPs) be written and approved An independent Quality unit (like Quality Control and/or Quality Assurance) Well trained personnel and management

GMP at End: 

GMP at End Good Management Practice Good Manufacturing Practice Get More Profit Give more Production GMP Training with out tears. OR GMP Getting More Pain ???????

PowerPoint Presentation: 

THANK YOU NEXT…….. cGMP