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of MBA (Biotechnology Management) Degree of AMITY UNIVERSITY, UTTAR PRADESH EKTA SINGH A0500109042
Under the supervision of Mr. JITENDER SINGH ARCH VITALIFE LABORATORIES AMITY INSTITUTE OF BIOTECHNOLOGY AMITY UNIVERSITY, UTTAR PRADESH SECTOR-125, NOIDA, 201301
This is to certify that Ms. EKTA SINGH of Amity Institute of Biotechnology has done a summer internship report entitled “QUALITY ASSURANCE IN ARCH VITALIFE LABORATORIES” in the partial fulfillment of Master of Business Administration as required under the rules of Amity University and has successfully completed it under the guidance of Mr. JITENDER SINGH
Director General Signature
I, EKTA SINGH, declare that the project report entitled “QUALITY ASSURANCE IN ARCH VITALIFE LABORATORIES” submitted to the Amity Institute Of Biotechnology, Noida for the partial fulfillment for the award of the degree of MBA (Biotechnology Management) is an authentic record of the work carried out by me under the guidance of Mr. JITENDER SINGH General Manager (QA), Arch Vitalife Laboratories. No part of this has been submitted for any degree, diploma title of recognition before.
EKTA SINGH A0500109042
who has provided me with guidance. love and support have enabled me to reach this level. Raghav (Sr. I express my heartfelt thanks to my mentor in college Ms. Digvijay (Sr.ACKNOWLEDGEMENT I am overwhelmed with respect and my deep sense of gratitude to my college for assigning me such training opportunity which opened my vision towards practical experience of the theory implications.). P.). directing me towards right path and for the completion of the project. microbiologist. I would like to extend my sincere thanks to Mr. Mr.Manager-HR & Admin. Microbiology lab) and all others in the company for acting as the constant motivating force for. Manvendra Singh (Head. I have all my appreciation and respect for my parents whose unfailing inspiration. inspiration. Mr. perspective and stimulating discussion throughout the writing of this project. Sudha Balram (Program Coordinator) and all faculty members in my institute and also my mentor in company Mr. QA) Arch Vitalife Laboratories. EKTA SINGH 4 . And I would like to thank my friends and all the people who are involved in this project report directly or indirectly.S. Jitender Singh (General Manager. Microbiology lab.
VISION AND VALUES COMPANY OVERVIEW PRODUCTS OF THE COMPANY MANUFACTURING SITES FACILITIES CETIFICATES ENVIRONMENTAL. HEALTH AND SAFETY CORE STRENGTHS OF THE COMPANY QUALITY ASSURANCE QUALITY ASSURANCE SYSTEM QUALITY MANAGEMENT IN DRUG INDUSTRY QUALITY ASSURANCE PROCESSING GMP’s FOR PHARMACEUTICAL PRODUCTS QUALIFICATION AND VALIDATION QUALITY AUDITS DOCUMENTATIONS DOCUMENTS REQUIRED SOP’s AND RECORDS GOOD PRACTICES IN PRODUCTION GOOD PRACTICES IN QUALITY CONTROL QUALITY ASSURANCE STANDARDS CONCLUSION RECOMMENDATIONS REFERENCES 6 8 9 10 11 24 27 29 31 32 34 35 38 40 43 45 49 53 55 62 65 67 70 72 73 75 5 .CONTENTS • • • • • • • • • • • • • • • • • • • • • • • • • • INTRODUCTION EXECUTIVE SUMMARY MISSION.
500 customer-centric Archers are helping global pharmaceutical companies to efficiently and reliably transform their molecules into products. Of course. Arch Vitalife works. Generating revenues of USD 200 million.400 customercentric Archers.Arch Pharmalabs has gained recognition as a world-class provider of small molecule process chemistry. insurance coverage and growth in lifestyle diseases is also exhibiting a robust growth ARCH VITALIFE LABORATORIES Founded in 1999.INTRODUCTION Knowledge. custom synthesis services and full life-cycle API and drug intermediates manufacture for the global pharmaceutical industry. US FDA. our India-based offering is supported by 2. Supported by eleven India-based certified facilities (including cGMP. that’s what Arch brings to your small molecules API and drug intermediate goals.and EDQM-approved sites) and two state-of-the-art Process Technology centres. 40905126. reducing costs and growing profitability Growth of Arch Pharmalabs Ltd in Pharma industry The industry overall has been growing at a rate of 8-10% over the years. experience. The domestic market on the back of higher healthcare penetration. our 2. This could get more pronounced in the wake of resizing of operations and migration of production to India by major pharma companies in the US & Europe. this is based on the premise that Indian companies gear up to challenges of a stricter regulatory and environmental regime.doc For early development to launch planning and life cycle management. EDQM. US FDA. integrity and result!!! This is on what. eleven certified facilities (including cGMP-compliant. 6 . TGA and Japanese approved assets) and two state-of-the-art Process Technology Centres.
many of whom have designated Arch Pharmalabs as a Preferred Supplier or Strategic Partner. innovation and effective supply chain solutions in the spirit of true partnership. Our large family of satisfied customers range from emerging or specialty companies to global majors. Arch Pharmalabs received CNBC TV Emerging India 2006 Award as the No.1 Small or Medium Company in the Pharmaceuticals and Chemicals category 7 .Arch Pharmalabs works tirelessly to deliver value.
EXECUTIVE SUMMARY STATEMENT OF PROJECT Project is to study the practical implications of quality assurance in the working of Arch Vitalife Laboratories 9 .
This leads to improved quality and less rework. This results in more business for the organization and further increasing profits. low costs and high quality. the report emphasizes on the history. Led by a diverse group of seasoned industry professionals. Arch’s core strength comes from 10 . Arch Pharmalabs management team brings a vast array of domain expertise and experience to developing innovative. VISION AND VALUES Arch Pharmalabs aims to be a world leader in the development. speed. MISSION. Finance & Accounts department. yet practical and cost-effective R&D and manufacturing solutions for our customers. business & latest developments of ARCH VITALIFE LABORATORIES. Initially.OBJECTIVE OF THE PROJECT The main objective of the project is to know the practical impact and implication of the theoretical knowledge of the quality assurance in the industry. Engineering dept. It also emphasizes on the functioning of various departments of Arch Vitalife including QC. etc. Our mission is to consistently exceed our customers’ expectations through innovation. Labs. Our executives cherish customer-centricity as the cornerstone of a successful global business. The company has put an effort in working out with proper adoption of quality assurance in the industry and to take full fledged benefit out of it. The systems are integrated in the whole organization to deliver good quality products or services. manufacture and supply of Active Pharmaceutical Ingredients and intermediates across the life cycle for the global drug industry.
Working diligently to produce success for our customers and partners across the world. while helping them to realize personal excellence and growth goals. who are dedicated to developing practical. accountability and a long-term approach are cornerstones of our business philosophy. yet highly cost-effective solutions for the unique challenges of pharmaceutical product development and commercialization We are committed to working transparently with our customers in the spirit of true partnership and providing them with the best value. Integrity. We take pride in being responsible. while delivering superior returns to our shareholders. global corporate citizens and stewards of the environment.our highly skilled and experienced customer-centric people. rapid. We have a "Zero Compete" position with our customers. Our service model is 11 . Our colleagues are “Archers” and we create the best atmosphere for them to hit the mark. quality-focused. Arch Pharmalabs is transforming the way chemistry and manufacturing are outsourced COMPANY OVER VIEW PARTNERS AND CUSTOMERS We service various customers with APIs and intermediates used in Pharmaceutical industry. results.
2 bank). This is highly customized business which combines various skills for value creation and sharing. who collectively own 58% of the Company PRODUCTS OF THE COMPANY 1. API’s (Active Pharmaceutical Ingredients) 2.founded on basic principle that "Our customers' success is our success". INVESTORS Arch Pharmalabs is backed by marquee investors ICICI Ventures (venture arm of India's No. Pharma Intermediates 12 . Swisstec Ventures (venture arm of the Swiss Federal Government) and IL&FS.
1 2 3 4 5 Product Name Atorvastatin calcium (Amorphous) Atorvastatin calcium (Crystalline) Amlodipine besylate Clopidogrel bisulphate (Form I) Clopidogrel bisulphate (Form II) Perindopril erbumine Trandolapril Budesonide Ciclesonide Fluticasone propionate Mometasone furoate Montelukast sodium# Fluconazole Cetirizine dihydrochloride Levocetirizine dihydrochloride Fexofenadine hydrochloride Docetaxel anhydrous Gemcitabine hydrochloride Paclitaxel hydrochloride Capecitabine Artesunate sodium Alpha beta arteether Artemether Lumefantrine Chlorothiazide Hydrochlorothiazide Zopiclone Citalopram hydrobromide Escitalopram oxalate Duloxetine hydrochloride# Therapeutic Segment Lipid Lowering Agent Calcium Channel Blocker Anti Platelet Agent ACE Inhibitor Anti Asthmatic 6 7 Anti Fungal Anti Histamine 8 Anti Cancer 9 Anti Malarial 10 11 12 Diuretic Sedative-Hypnotic Anti Depressant 13 . No.API’s (Active Pharmaceutical Ingredients) Sr.
13 Milnacipran Pregabalin Efavirenz Anti Convulsant Anti Retroviral 14 Lamivudine Stavudine Zidovudine Nevirapine Ritonavir 15 16 17 18 Pantoprazole sodium Rabeprazole sodium Bromhexine hydrochloride Naproxen Bromfenac Ephedrine hydrochloride Pseudoephedrine hydrochloride Ephedrine sulfate Pseudoephedrine sulfate Pramipexole dihydrochloride Monohydrate entacapone Ibuprofen S (+) Ibuprofen S (+) Ibuprofen DC MeloxicamB Piroxicam Diclofenac sodium Aceclofenac MeFenamic acid Loratadine Isradipine Lacidipine Proton Pump Inhibitor Expectorant NSAIDs Decongestant 19 Anti parkinsonian 20 NSAIDs 21 22 Anti histamine Calcium channel blockers 14 .
PHARMA INTERMEDIATES 15 .
6 Dichlorophenyl)-5-methyl isoxazole-4-carbonyl chloride 4462-55. 1 Intermediate CAS No.408-050-9 69-1 (ELINCS) Carbapenem New (3R.3-dioxopiperazine carbonyl chloride 59703.4R)-4-Acetoxy-3-[(R)-1- 16 115-46-8 204-092-5 Fexofenadine 8 . EINECS No.224-723-8 9 Dicloxacillin 3 FCMIC Chloride: 3-(2-Chloro-6-fluorophenyl)-5methyl isoxazole-4-carbonyl chloride 69399.273-987-0 79-7 Flucloxacillin 4 PMIC Chloride: 3-Phenyl-5-methyl isoxazole-4carbonyl chloride 16883. No.Sr.240-915-4 16-2 Oxacillin 5 EDPCC: 4-Ethyl-2.261-867-0 00-3 Piperacillin 6 EPCP: (R)-[[(4-Ethyl-2. Structure End use Pharma Intermediates CMIC Chloride: 3-(2-Chlorophenyl)-5-methyl isoxazole-4-carbonyl chloride 25629.3dioxopiperazin-1yl)carbonyl]amino]phenylacetic acid 63422.264-133-8 71-9 Piperacillin 7 AOSA# (tert-butyldimethylsilyloxy)ethyl]azetidin2-one Azacyclonol base: 76855.247-137-4 50-9 Cloxacillin 2 DCMIC Chloride: 3-(2.
to cater to the changing needs of its customers worldwide. All factories are equipped with proper effluent treatment and solvent recovery systems in line with regulatory requirements 1. Intermediates manufacturing sites 17 .MANUFACTURING SITES Arch has multi-locational manufacturing facilities in India. API manufacturing sites 2. It believes in teamwork that transcends organizational and geographic boundaries. It has also augmented its manufacturing strength through strategic alliances and co-marketing agreements.
API -MANUFACTURING SITES 1. Vitalife site , Gurgaon - Located in northern India at Gurgaon near New Delhi, this USFDA inspected, WHO-cGMP compliant site manufactures various APIs in different therapeutic segments. This multipurpose facility handles diverse chemistry range using n-BuLi, diethyl zinc and biocatalysts 2. Avon site , Solapur - Located in western India at Solapur, this USFDA inspected site is the largest manufacturer of Ephedrine and Pseudoephedrine in India. In addition to fermentation capabilities, this site has a multipurpose plant for manufacturing APIs. 3. Sibra site, Hyderabad - Located in southern India at Hyderabad, this cGMP compliant site has capability to manufacture various APIs in the Anti Retroviral segment. The site handles biocatalysts, cyanides and azide based reactions. 4. Oncology site, Tarapur - Located in western India at Tarapur near Mumbai, this cGMP compliant site handles various APIs in the oncology segment. The site has state of the art isolation and containment systems in place to handle high potency products 5. Dombivali site, near Mumbai - Located in western India at Dombivali near Mumbai, this cGMP facility, with capabilities of handling complex chemical
reactions, is a USFDA, TGA and EDQM inspected site with over 15 APIs being manufactured here.
INTERMEDIATES MANUFACTURING SITES 1. Merven site, Hyderabad - Located in southern India at Hyderabad, this site has capacity to produce Isoxazole side chain intermediates in multiple ton quantities; thus making Arch its largest producer in the world. In addition, it has capability to handle diverse chemistries using n-BuLi, triphosgene and biocatalysts making it a multipurpose facility to make advanced intermediates for various therapeutic segments 2. Watsol site, Hyderabad - Located in southern India at Hyderabad, this site manufactures Isoxazole based side chain intermediates and phosphorus chemicals in multiple ton quantities 3. Avon site, Hyderabad - Located in southern India at Hyderabad, this site manufactures diketene and its downstream intermediates. It is a multipurpose facility to make various advanced intermediates. 4. Badlapur site, near Mumbai - Located in western India at Badlapur near Mumbai, this site manufactures Intermediates and APIs. This multipurpose facility is used for scale up and custom synthesis projects 5. Tarapur site, near Mumbai - Located in western India at Tarapur near Mumbai, this site manufactures advanced intermediates for key APIs
6. Chromato site, Taloja - Located in western India at Taloja near Mumbai, this site manufactures Intermediates and steroids (Class-III). This is a multipurpose facility used for scale up and custom synthesis project
PROCESS R&D Working in state-of-the-art laboratories and supported by excellent in-house analytical capabilities, our talented and experienced scientists work across multiple chemistry and therapeutic categories to create scalable, robust and cost-effective processes. Arch Pharmalabs provides flexible Full Time Equivalent (FTE) or per-project arrangements to execute innovative route scouting, process R&D and rapid-response custom synthesis of regulatory starting materials, advanced intermediates and APIs in gram to multi kilo gram quantities as per customers' demand. PROCESS TECHNOLOGY CENTRE Located in Taloja (near Mumbai), Arch Pharmalabs Process Technology Centre spearheads: • • Externally sponsored process R&D and custom synthesis of new chemical entities Continuous process improvement and expansion of our API portfolio
The site houses 150 process chemists and analysts and features professional project management, state-of-the-art chemistry laboratories and analytical instrumentation. Kilo laboratories and Pilot Plant assets enable rapid scale-up of APIs and intermediates for timeline-sensitive pre-clinical animal GLP tox and Phase I human studies.
our production.CLINICAL TRIALS SUPPLIES MANUFACTURE We fully understand the critical importance of time. Applying world-class best practices. PROCESS VALIDATION Arch Pharmalabs product development and commercialization track record offers customers and partners a unique opportunity to leverage our expertise and experience in process validation and launch planning.and / or DMF-related supporting documentation and assistance to enable smooth filings COMMERCIAL MANUFACTURE Arch Pharmalabs offers multiple manufacturing locations and flexible assets in India to provide our customers post-approval. quality and economics in pharmaceutical development. quality and supply chain teams work diligently to enable customers' launch and post-approval commercial supply programs on a global basis. quality-focused and economical manner. communications and delivery. market place requirements of regulatory starting materials. Arch Pharmalabs project management systems enable transparent milestone tracking. II & III clinical trials in kilo gram to metric tonne quantities. 21 . Our New Product Introduction teams work closely with customers to plan and execute a safe. cost-effective and risk-mitigated validation strategy. intermediates and APIs for Phase I. Our regulatory team provides all API CMC. QC analytics. intermediates and APIs in a reliable. manufacturing teams and project champions work hand-in-hand with customer to produce regulatory starting materials. Our customer-centric process R & D.
CERTIFICATES 22 .
INSPECTIONS AND COMPLIANCES CERTIFICATE 23 .
In addition... Arch Pharmalabs routinely receives GMP / GLP / EHS audits in preparation for site registration from current and prospective customers from across the world. ENVIRONMENTAL. UK or International Certifications Ltd.Arch Pharmalabs Avon GMP manufacturing facility (Solapur. 19744 and 20681. 17953. All Arch Pharmalabs sites have ISO 9001:2000 or ISO 140001 certifications as authenticated by QA International Certification Ltd. HEALTH AND SAFETY 24 . including Top 10 companies. Arch Pharmalabs has submitted Type II DMFs with the following DMF Numbers to the USFDA: 17693. 17954. Our Vitalife GMP manufacturing unit expects a USFDA inspection in 2009 and has successfully received more than 7 full GMP / QA audits from global majors. 18215. New Zealand. Maharashtra) successfully received a USFDA audit and is approved for supply of a bulk API. 20444.
personnel health and continuous reinforcement of principles through regular training. Our teams constantly reinforce these principles through ongoing training programs. Arch Pharmalabs is dedicated to the protection of the environment and safety of both employees and the public at large. while maintaining safety. prior to release. scrubbers and solid waste management systems Medical facilities and Physician check-ups are available either on-site or through nearby hospitals. 7 days a week. internationally accepted manufacturing practices and take special care in the handling and disposal of all potentially hazardous substances and waste products per applicable codes. proper inventory control of hazardous substances and easy access to fire extinguishers and other mitigation techniques throughout our laboratory and production facilities. Our sites have effluent treatment plants ensuring zero discharge at point of manufacture and waste water treatment to applicable standards. Other available equipment includes multiple effect evaporators. Risk assessment is an integral part of scaling up new processes at Arch Pharmalabs. Large-scale production facilities maintain an on-site ambulance service 24 hours a day. incinerators. We are firmly committed to the highest. These practices include hazard assessment..Arch Pharmalabs has instituted an environmental. health and safety program to ensure strict compliance with Local as well as Central Government regulations and industry best practices. CORE STRENGTHS OF COMPANY 25 .
3. The company is engaged in the manufacture of Oncology and Anti Malarial APIs.Our core strength is the ability to differentiate in a highly commoditised and fragmented space. OPPORTUNITIES AND CHALLENGES 26 . The capital expenditure during this period is expected to be around Rs1. The differentiation is based on the following : 1. Offering of products in every therapeutic segment Our positioning by way of market/co-market leadership in various products both globally and in the domestic market. the company had finalised and embarked on expansion plans in the existing locations. Reliance on R&D services which has helped us attract business from innovator companies. Besides. Assimilation of new technology on the back of our technical collaboration with two partners viz. the acquisition offered an entry to Arch in the Oncology space. EXPANSION PLANS OF THE INDUSTRY The company has been at the forefront of consolidation in the Indian API industry. Multiple facilities with ability to handle complex reactions at various scales. we will explore acquisitions either from a point of enhancement of capacities . we will explore meaningful acquisitions either from a point of enhancement of capacities. 2. Codexis Inc ( USA) and DSM ( EU). For the year 2009. For the year 2009. Limited. 4. The company has been at the forefront of consolidation in the Indian API industry. Based near Mumbai. backward integration or therapeutic segment extension. RECENT ACQUISITION BY THE COMPANY We have acquired Benzochem Lifesciences Pvt.5bn. backward integration or therapeutic segment extension.
The services revolved around custom synthesis. offer of Full Time Equivalence business model. at times. R&D BY INDUSTRY Arch has two Corporate R&D centres besides Process Development labs at various locations. As the world goes " generic" . The challenges for the industry are primarily the following : a. b. The Centres are equipped with state of the art analytical equipment and built to international working and safety standards. Clearly India and China appear to be the beneficiaries of these moves. more so in the peripheral but highly critical functions of documentation. The Corporate R&D centre focuses on offering services to both innovator and generic companies. Currently. Shortage of skilled personnel. quality control and assurance etc. scale up of hitherto untested processes and assist our various manufacturing facilities for perpetual cost reduction programmes. QUALITY ASSURANCE 27 . there are over 250 Chemists working in our R&D Centres and we expect to ramp up our bench strength to over 350 in 2009. there are bound to be pressures on the realisations. c. Highly fragmented industry in both India and China leading to overcapacity and irrational pricing. Higher investments in the face of stricter environmental & regulatory compliances.The opportunities for the industry stem from a growing domestic market and demand. This is in addition to the opportunities flowing in from the US & Europe where major pharma companies are engaged in resizing their operations given the fact that we are moving towards a growing generic market.
and Audit of the final output for conformance to 1. Performance requirements 28 . and issue of material. Definition often used interchangeably with quality control (QC). safety. and reliability standards. it is a wider concept that covers all policies and systematic activities implemented within a quality system. Reliability.Quality assurance is a process in which steps are taken to make sure that a company's products or services are of sufficiently high quality or are up to the mark of specified values. QA frameworks include – • • • Determination of adequate technical requirement of inputs and outputs. Maintainability. Evaluation of the process to establish required corrective response. technical 2. 3. • • • • Proper receipt. Certification and rating of suppliers. and 4. storage. Audit of the process quality. Testing of procured material for its conformance to established quality. performance.
Additionally.QUALITY ASSURANCE SYSTEM Quality Assurance System that is based on a continuous cycle of five stages:-• • • • data collection. and improvement and changes. practices a culture of inquiry that allows the concern to learn more about itself and the services that it provides. (Figure) depicts this cycle. data and analysis dissemination. data analysis. which in turn results in improved services. This system functions as an umbrella under which our quality efforts take place. different cycles are established. Depending on the nature of the data source and the collection activity. decision-making. By following this cycle for activities such as program reviews other evaluations. such a system creates the path to make decisions based on wellanalyzed data. 29 .
Quality Assurance Cycle 31 .
QUALITY MANAGEMENT IN DRUG INDUSTRY 32 .
procedures. The basic elements of quality management are:-• • an appropriate infrastructure or “quality system”. In contractual situations.e. quality assurance serves as a management tool. the overall intention and direction of an organization regarding quality. systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. as formally expressed and authorized by top management. i. Within an organization. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.Philosophy and essential elementsIn the drug industry at large. processes and resources. 33 . quality management is usually defined as the aspect of management function that determines and implements the “quality policy”. The totality of these actions is termed “quality assurance”. GMP and quality control are interrelated aspects of quality management. The concepts of quality assurance. quality assurance also serves to generate confidence in the supplier. encompassing the organizational structure.
QUALITY ASSURANCE CYCLE 34 .
calibrations. intermediate products. and bulk products and other in-process controls. supply and use of the correct starting and packaging materials. according to the defined procedures. • the finished product is correctly processed and checked. arrangements are made for the manufacture. • pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance 35 . • • managerial responsibilities are clearly specified in job descriptions. • all necessary controls on starting materials. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors. including those outside the scope of this guide such as product design and development. • production and control operations are clearly specified in a written form and GMP requirements are adopted. The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that: • pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP).QUALITY ASSURANCE PROCESSING “Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. and validations are carried out.
The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company. control and release of pharmaceutical products.with the requirements of the marketing authorization and any other regulations relevant to the production. distributed. • there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. All parts of the quality assurance system should be adequately staffed with competent personnel. and should have suitable and sufficient premises. 36 . • satisfactory arrangements exist to ensure. equipment. and the distributors. that the pharmaceutical products are stored by the manufacturer. and subsequently handled so that quality is maintained throughout their shelf-life. as far as possible. It should be fully documented and its effectiveness monitored. • regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement. the company’s suppliers. and facilities.
(vi) suitable storage and transport. containers and labels. all necessary resources are provided. (vii) adequate personnel.cross-contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by. including:(i) appropriately qualified and trained personnel. Such risks are essentially of two types:-. laboratories and equipment for in-process controls. 38 .. for example. (ii) adequate premises and space. (iii) suitable equipment and services. • • qualification and validation are performed. (v) approved procedures and instructions. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. specifically applicable to the facilities provided.false labels being put on containers. • • instructions and procedures are written in clear and unambiguous language. systematically reviewed in the light of experience. (iv) appropriate materials. and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications. operators are trained to carry out procedures correctly. Under GMP:-• all manufacturing processes are clearly defined.GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS (GMP) Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
production materials and containers. are retained in a comprehensible and accessible form. • • • • records covering manufacture and distribution.• records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. which enable the complete history of a batch to be traced. complaints about marketed products are examined. The scope of sanitation and hygiene covers personnel. a system is available to recall any batch of product from sale or supply. the proper storage and distribution of the products minimizes any risk to their quality. equipment and apparatus. and anything that could become a source of contamination to the product. and appropriate measures taken in respect of the defective products to prevent recurrence. SANITATION AND HYGIENE A high level of sanitation and hygiene should be practised in every aspect of the manufacture of drug products. any significant deviations are fully recorded and investigated. products for cleaning and disinfection. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene. premises. the causes of quality defects investigated. 39 .
or PV. supporting utilities and equipment have been built and installed in compliance with their design specifications (installation qualification. 40 . each pharmaceutical company should identify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled . a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (process validation. • Validation studies are an essential part of GMP and should be conducted in accordance with predefined and approved protocols. supporting utilities. the premises. facilities. or DQ). • Qualification and validation should not be considered as one-off exercises.QUALIFICATION AND VALIDATION In accordance with GMP. • The commitment to maintain continued validation status should be stated in the relevant company documentation. or OQ). also called performance qualification. The responsibility of performing validation should be clearly defined. including significant changes to the premises. directly or indirectly. Qualification and validation should establish and provide documentary evidence that:• • • • the premises. The key elements of a qualification and validation programme of a company should be clearly defined and documented in a validation master plan. An ongoing program should follow their first implementation and should be based on an annual review. the premises. • Any aspect of operation. or PQ). which may affect the quality of the product. such as the quality manual or validation master plan. supporting utilities and equipment operate in accordance with their design specifications (operational qualification. or IQ). equipment or processes. should be qualified and validated. equipment and processes have been designed in accordance with the requirements for GMP (design qualification.
41 . • There should be written procedures describing the action to be taken. • A person responsible for handling the complaints and deciding the measures to be taken should be designated. Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. including the need to consider a recall. in the case of a complaint concerning a possible product defect. In particular. • Where necessary. should be taken after investigation and evaluation of the complaint. investigation or recall. If this person is different from the authorized person. consideration should be given to whether other batches should be checked in order to determine whether they are also affected. • • Special attention should be given to establishing whether a complaint was caused because of counterfeiting. Processes and procedures should be established on the basis of the results of the validation performed. The person responsible for quality control should normally be involved in the review of such investigations. other batches that may contain reprocessed product from the defective batch should be investigated. possibly including product recall. appropriate follow-up action. together with sufficient supporting staff to assist him or her. It is of critical importance that particular attention is paid to the validation of analytical test methods. COMPLAINTS • All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken. automated systems and cleaning procedures. the latter should be made aware of any complaint. • If a product defect is discovered or suspected in a batch.• • • A written report summarizing the results recorded and the conclusions reached should be prepared and stored.
42 . Recall operations should be capable of being initiated promptly down to the required level in the distribution chain. • The distribution records should be readily available to the authorized person. and they should contain sufficient information on wholesalers and directly supplied customers (including. for the organization of any recall activity.• • All decisions made and measures taken as a result of a complaint should be recorded and referenced to the corresponding batch records. promptly and effectively. for exported products. A final report should be issued. defective. or is suspected of being. The authorized person should be responsible for the execution and coordination of recalls. counterfeiting or any other serious quality problems with a product. • The competent authorities should be informed if a manufacturer is considering action following possibly faulty manufacture. • There should be established written procedures. competent authorities of all countries to which a given product has been distributed should be promptly informed of any intention to recall the product because it is. products known or suspected to be defective. • • An instruction should be included in the written procedures to store recalled products in a secure segregated area while their fate is decided. product deterioration. He/she should have sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency. Records should include the disposition of the product. Complaints records should be regularly reviewed for any indication of specific or recurring problems that require attention and might justify the recall of marketed products. PRODUCT RECALL There should be a system to recall from the market. those who have received samples for clinical tests and medical samples) to permit an effective recall. • The progress of the recall process should be monitored and recorded. which are regularly reviewed and updated.
agreed and controlled in order to avoid misunderstandings that could result in a product or work or analysis of unsatisfactory quality. 43 . CONTRACT PRODUCTION AND ANALYSIS Contract production and analysis must be correctly defined. • The effectiveness of the arrangements for recalls should be tested and evaluated from time to time.including a reconciliation between the delivered and recovered quantities of the products.
Individual responsibilities should be clearly defined and understood by the persons concerned and recorded as written descriptions. Their education should include the study of an appropriate combination of:-• • • • • • chemistry (analytical or organic) or biochemistry. in the case of product recalls or repeated rejections. 44 . performed on special occasions. chemical engineering.g. and may be. The self inspection programme should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. pharmaceutical sciences and technology. and there should be an effective follow-up programme. in addition. The procedure for self-inspection should be documented. All recommendations for corrective action should be implemented. physiology. PERSONNEL The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture and control of pharmaceutical products and active ingredients rely upon people. e. For this reason there must be sufficient qualified personnel to carry out all the tasks for which the manufacturer is responsible. or when an inspection by the health authorities is announced. The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively. Self-inspections should be performed routinely. pharmacology and toxicology. Key personnel responsible for supervising the manufacture and quality control of pharmaceutical products should possess the qualifications of a scientific education and practical experience required by national legislation. microbiology.QUALITY AUDITS The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control.
and approval by. subdivision of output batches from a common input. approval has been given by the head of quality control. 45 . The person responsible for approving a batch for release should always ensure that the following requirements have been met:-• • • • • the marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned. tests and checks have been carried out or initiated. the principal manufacturing and testing processes have been validated. factors associated with continuous production runs). any planned changes or deviations in manufacturing or quality control have been notified in accordance with a well defined reporting system before any product is released. as laid down in the guidelines published by WHO. Such changes may need notification to. inspection. as appropriate. have been followed. to cover planned changes and deviations. all necessary production and quality control documentation has been completed and endorsed by supervisors trained in appropriate disciplines. the principles and guidelines of GMP. if different. all relevant factors have been considered. including any not specifically associated with the output batch directly under review (e.g.• other related sciences. all the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records. the drug regulatory authority. self-inspections and spot-checks are carried out by experienced and trained staff. • • • • • any additional sampling. appropriate audits.
should be given specific training. designed. • Besides basic training on the theory and practice of GMP. clean areas or areas where highly active. in general. and. and its practical effectiveness periodically assessed. • The concept of quality assurance and all the measures which aid its understanding and implementation should be fully discussed during the training sessions. constructed. Evidence of this should be included in the training records. they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. 46 . adapted. Training records should be kept. • Personnel working in areas where contamination is a hazard. newly recruited personnel should receive training appropriate to the duties assigned to them. any adverse effect on the quality of products. They should be closely supervised. The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination. infectious or sensitizing materials are handled.TRAINING • The manufacturer should provide training in accordance with a written programme for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical. • Consultant and contract staff should be qualified for the services they provide. e. maintenance and cleaning personnel) and for other personnel as required. build-up of dust or dirt.g. Continuing training should also be given. toxic. PREMISES Premises must be located. • Visitors or untrained personnel should preferably not be taken into the production and quality control areas. and maintained to suit the operations to be carried out. Approved training programmes should be available. If this is unavoidable.
in general. Where possible. directly from the producer. labelling and packaging requirements as well as complaints and rejection procedures. Where additional labels are attached to containers. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid crosscontamination. any adverse effect on the quality of products. packaging materials. build-up of dust or dirt.g. are contractually agreed between the manufacturer and the supplier. such materials should be of a suitable grade (e. • It is of benefit that all critical aspects of the production and control of the starting material in question. solvents. and. where possible. constructed. adapted. Containers should be cleaned where necessary and labelled. with the prescribed information. and maintained to suit the operations to be carried out. gases. designed. including handling. 47 . if required. • All incoming materials should be checked to ensure that the consignment corresponds to the order. MATERIALS The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a combination of materials (starting and packaging). • Starting materials should be purchased only from approved suppliers and. process aids. No materials used for operations such as cleaning. reagents and labelling materials. lubrication of equipment and pest control. the original information should not be lost. It is also recommended that the specifications established by the manufacturer for the starting materials be discussed with the suppliers.EQUIPMENT Equipment must be located. food grade) to minimize health risks. should come into direct contact with the product. • • Materials include starting materials.
48 . Its aims are to define the specifications and procedures for all materials and methods of manufacture and control. these entries should be clear. to ensure the existence of documented evidence.DOCUMENTATION Good documentation is an essential part of the quality assurance system and. No document should be changed without authorization and approval. They should comply with the relevant parts of the manufacturing and marketing authorizations. traceability. and to provide records and an audit trail that will permit investigation. to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale. but they will usually be separate. a system should exist to prevent inadvertent use of the superseded version. should exist for all aspects of GMP. review and statistical analysis. Reproduced documents should be clear and legible. They should be laid out in an orderly fashion and be easy to check. The design and use of documents depend upon the manufacturer. Sufficient space should be provided for such entries. as such. reviewed and distributed with care. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process. Documents should have unambiguous contents: the title. It ensures the availability of the data needed for validation. • • Documents should be approved. nature and purpose should be clearly stated. to ensure that all personnel concerned with manufacture know what to do and when to do it. • Documents should be designed. Superseded documents should be retained for a specific period of time. • Where documents require the entry of data. In some cases some or all of the documents described below may be brought together. • Documents should be regularly reviewed and kept up to date. prepared. legible and indelible. When a document has been revised. signed and dated by the appropriate responsible persons.
• Any alteration made to a document should be signed and dated. 49 . • • access should be restricted by passwords or other means and the entry of critical data should be independently checked. the reason for the alteration should be recorded. the alteration should permit the reading of the original information. during the period of retention. paper print-outs or other means. Batch records stored electronically should be protected by back-up transfer on magnetic tape. • • Data (and records for storage) may be recorded by electronic dataprocessing systems or by photographic or other reliable means. and there should be a record of changes and deletions. microfilm. only authorized persons should be able to enter or modify data in the computer. • If documentation is handled by electronic data-processing methods. • Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable. Records should be retained for at least one year after the expiry date of the finished product. the data are readily available. Master formulae and detailed standard operating procedures relating to the system in use should be available and the accuracy of the records should be checked. It is particularly important that. Where appropriate.
(g) the name and address of the manufacturer or the company or the person responsible for placing the product on the market. unambiguous and in the company’s agreed format. • For reference standards. storage conditions and control number. accepted.DOCUMENTS REQUIRED LABELS • Labels applied to containers. (c) the batch number assigned by the manufacturer. (d) the expiry date in an uncoded form. (b) a list of the active ingredients. (f) directions for use. 50 . expiry date. date the closure is first opened. as appropriate. quarantined. date of manufacture. and warnings and precautions that may be necessary. the label and/or accompanying document should indicate potency or concentration. (e) any special storage conditions or handling precautions that may be necessary. • All finished drug products should be identified by labelling. as required by the national legislation. equipment or premises should be clear.g. bearing at least the following information: (a) the name of the drug product. It is often helpful in addition to the wording on the labels to use colours to indicate status (e. clean). rejected.
Pharmacopoeias. they should also be available for intermediate or bulk products. if any. and maintained by quality control. primary and printed packaging materials should provide. (e) the maximum period of storage before re-examination. solvents and reagents (e. (b) the reference. There should be appropriately authorized and dated specifications. (d) storage conditions and precautions. if applicable. • Depending on the company’s practice other data may be added to the specification. or a reference to procedures. (c) directions for sampling and testing. Specifications for starting and packaging materials • Specifications for starting. (b) a specimen of printed materials. including: (a) the designated name (if applicable. • • Periodic revisions of the specifications may be necessary to comply with new editions of the national pharmacopoeia or other official compendia. purity and quality. including tests on identity. acids and bases) used in production should be included. reference standards. and bulk. to a pharmacopoeial monograph. where appropriate. a description of the materials. Specifications for starting materials. reference spectra and other reference materials should be available in the quality control laboratory. finished products and packaging materials are referred to in sections.g. signed and dated. • Each specification should be approved. content. for starting and packaging materials and for finished products. Specifications for water. intermediates. (c) qualitative and quantitative requirements with acceptance limits. the INN) and internal code reference. such as: (a) the supplier and the original producer of the materials.SPECIFICATIONS AND TESTING PROCEDURES • • Testing procedures described in documents should be validated in the context of available facilities and equipment before they are adopted for routine testing. 51 . quality assurance unit or documentation centre.
as appropriate. The specifications should be similar to specifications for starting materials or for finished products. as determined by its stability. Specifications for finished products • Specifications for finished products should include: (a) the designated name of the product and the code reference. with acceptance limits. (g) the storage conditions and precautions. (d) a description of the dosage form and package details. (h) the shelf-life. 52 . and should be compatible with the material and/or with the drug product it contains. The material should be examined for compliance with the specification. and for defects as well as for the correctness of identity markings. Specifications for intermediate and bulk products • Specifications for intermediate and bulk products should be available. where applicable. where applicable. (e) directions for sampling and testing or a reference to procedures.• Packaging material should conform to specifications. • Documents describing testing procedures should state the required frequency for re-assaying each starting material. (b) the designated name(s) of the active ingredient(s) (c) the formula or a reference to the formula. (f) the qualitative and quantitative requirements.
4. the methods. 3. The master formula should include:-1. calibrating. pretreatments. 7. 2. any special precautions to be observed. detailed step-wise processing instructions (e. 6. e. assembling. mixing times. where applicable. to be used for preparing and operating the critical equipment. checks on materials. the instructions for any in-process controls with their limits. 9. described using the designated name and a reference that is unique to that material (mention should be made of any substance that may disappear in the course of processing). 8. and of relevant intermediate yields. sterilizing. cleaning (especially after a change in product).g. a description of the dosage form. use. with a product reference code relating to its specification. a statement of the processing location and the principal equipment to be used. 53 . including the container. temperatures). strength of the product and batch size. where necessary. sequence for adding materials. and any special storage conditions. or reference to the methods.g. the requirements for storage of the products. the labelling.MASTER FORMULAE • • A formally authorized master formula should exist for each product and batch size to be manufactured. with the INNs). a statement of the expected final yield with the acceptable limits. 5. a list of all starting materials to be used (if applicable. with the amount of each. the name of the product.
the name of the product. details of in-process controls with instructions for sampling and acceptance limits.PACKAGING INSTRUCTIONS • Formally authorized packaging instructions should exist for each product. Transcribing from approved documents should be avoided. pack size and type. including any significant subsidiary operations. 8. indicating where the batch number and expiry date of the product have been marked. or materials not required 54 . and equipment to be used. (Copying or validated computer programmes are recommended. 3. an example or reproduction of the relevant printed packaging materials and specimens. It should be based on the relevant parts of the currently approved specifications on the record. sizes and types. 2. 6. with the code or reference number relating to the specifications for each packaging material. a complete list of all the packaging materials required for a standard batch size. or make reference to: 1. method of application. where appropriate. documents. These should normally include. 7. BATCH PROCESSING RECORDS • A batch processing record should be kept for each batch processed. strength and. a check should be made that the equipment and work station are clear of previous products. the pack size expressed in terms of the number. 5. The method of preparation of such records should be designed to avoid errors. special precautions to be observed. a description of the packaging operation. a description of its pharmaceutical form. 4. including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations. where applicable. including quantities.) • Before any processing begins. weight or volume of the product in the final container.
for the planned process. It should be based on the relevant parts of the approved packaging instructions. the amount of product obtained at different and pertinent stages of manufacture (yield). together with comments or explanations for significant deviations from the expected yield. the initials of the person(s) carrying them out. the name of the product. of significant intermediate stages. notes on special problems including details. BATCH PACKAGING RECORDS • A batch packaging record should be kept for each batch or part batch processed. 7. This check should be recorded.g. of the person(s) who checked each of these operations (e. 5. (Copying or validated computer programmes are recommended. 10. the in-process controls performed. the following information should be recorded at the time each action is taken. and after completion the record should be dated and signed by the person responsible for the processing operations:1. with signed authorization for any deviation from the master formula.) 55 . 9. and the results obtained. any relevant processing operation or event and the major equipment used. 6. 4. Transcribing from approved documents should be avoided. dates and times of commencement. and that the equipment is clean and suitable for use. the number of the batch being manufactured. and the method of preparing such records should be designed to avoid errors. weighing). 2. and of completion of production. the initials of the operator(s) of different significant steps of production and. 3. • During processing. the name of the person responsible for each stage of production. the batch number and/or analytical control number and the quantity of each starting material actually weighed (including the batch number and amount of any recovered or reprocessed material added). where appropriate. 8.
destroyed or returned to stock and the quantities of product obtained to permit an adequate reconciliation. including the results of in-process controls. and the date and the person responsible should be clearly identified by signature or electronic password:-1. the quantities and reference number or identification of all printed packaging materials and bulk product issued. used. as well as the batch number and the planned quantity of finished product that will be obtained. with written authorization by an appropriate person. checks should be made that the equipment and work station are clear of previous products. whenever possible. and that equipment is clean and suitable for use. the checks made for identity and conformity with the packaging instructions. 4. the instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area. the batch number and the quantity of bulk product to be packed. the quantity actually obtained and the reconciliation. when necessary. 2. samples of the printed packaging materials used. 5. 56 . the name of the product. documents or materials not required for the planned packaging operations. • The following information should be recorded at the time each action is taken.• Before any packaging operation begins. notes on any special problems. These checks should be recorded. and. including specimens bearing the approval for the printing of and regular check (where appropriate) of the batch number. 9. 7. details of the packaging operations carried out. the initials of the operators of the different significant steps. the date(s) and time(s) of the packaging operations. and any additional overprinting. 3. the name of the responsible person carrying out the packaging operation. including references to equipment and the packaging lines used. expiry date. including details of any deviation from the packaging instructions. 6. 8.
8. environmental monitoring. 57 . maintenance) and placed in close proximity to the equipment. if possible. recalls. 2. There should be standard operating procedures for the internal labelling. 5. The records of the receipts should include:-1. use. maintenance. clothing and hygiene. 3. the total quantity. the name of the material on the delivery note and the containers.g. cleaning and sanitization. 8. 4. 2.STANDARD OPERATING PROCEDURES (SOP’s) AND RECORDS Standard operating procedures and associated records of actions taken or. 9. the date of receipt. any relevant comment (e. and number of containers received. as appropriate. 4. • the manufacturer’s batch or reference number. where appropriate. manufacturer’s name 5. 7. 7. training. returns.g. analytical apparatus and calibration. conclusions reached should be available for:1. the “in-house” name and/or code of the material if different from (a). the supplier’s name and. 3. 6. • • There should be standard operating procedures and records for the receipt of each delivery of starting material and primary and printed packaging material. pest control. • Standard operating procedures should be available for each instrument and piece of equipment (e. 6. state of the containers). packaging materials and other materials. calibration. the batch number assigned after receipt. cleaning. equipment assembly and validation. personnel matters including qualification. complaints. quarantine and storage of starting materials.
• • There should be standard operating procedures for sampling. The tests performed should be recorded. instructions for any required subdivision of the sample. • The standard operating procedures for batch numbering that are applied to the processing stage and to the respective packaging stage should be related to each other. any precautions to be observed to avoid contamination of the material or any deterioration in its quality. in a logbook. e. which specify the person(s) authorized to take samples. 8. describing the methods and equipment to be used. and whether they are for aseptic sampling or for normal sampling. 4. • Analysis records should include at least the following data:-1. • There should be written procedures for testing materials and products at different stages of manufacture. • • The standard operating procedure for batch numbering should ensure that the same batch numbers will not be used repeatedly. 6. dosage form. 5.g. the amount(s) of sample(s) to be taken. the equipment to be used. where applicable. 58 . the method of sampling and the sampling plan. the name of the material or product and. with the objective of ensuring that each batch of intermediate. 2. Batch-number allocation should be immediately recorded. the type of sample container(s) to be used. The sampling instructions should include:-1. this applies also to reprocessing. any specific precautions to be observed. and labelling. 3. The record should include at least the date of allocation. bulk or finished product is identified with a specific batch number. especially in regard to the sampling of sterile or noxious material. 7. product identity and size of batch. There should be a standard operating procedure describing the details of the batch (lot) numbering system.
2. Such written procedures should be followed. the batch number and. 4. 6. • • The use of major and critical equipment and the areas where products have been processed should be appropriately recorded in chronological order. specifications (limits). e. of any validations. to facilitate the recall of the batch if necessary. as appropriate. including dates and the identity of the people who carried these operations out. or repair operations. • a clear statement of release or rejection (or other status decision) and the dated signature of the designated responsible person.g. where appropriate. There should be written procedures assigning responsibility for cleaning and sanitation and describing in sufficient detail the cleaning schedules. 3. the date and initials of the persons who verified the testing and the calculations. and in particular for the release for sale of the finished product by an authorized person. 8. methods. calibrations. including observations and calculations. test results. references to the relevant specifications and testing procedures. equipment and materials to be used and facilities and equipment to be cleaned. the initials of the persons who performed the testing. 7. • • Records should be maintained of the distribution of each batch of a product in order. Written release and rejection procedures should be available for materials and products. where appropriate. the manufacturer and/or supplier. cleaning. date(s) and reference number(s) of testing. 5. and reference to any 59 . maintenance. Records should be kept for major and critical equipment.
major items of equipment. 60 . labeling. storage. all materials. • All handling of materials and products. dispensing. recorded. • Any deviation from instructions or procedures should be avoided as far as possible. Where applicable. If deviations occur. sampling. The authorization of the deviation should be approved in writing by a designated person. such as receipt and cleaning. when appropriate. where necessary. processing. the rooms and packaging lines being used should be labelled or otherwise identified with an indication of the product or material being processed. In some cases it may be useful to record also the name of the previous product that has been processed. should be done in accordance with written procedures or instructions and. • Normally. non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products.GOOD PRACTICES IN PRODUCTION Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations. they should be done in accordance with an approved procedure. and where appropriate. bulk containers. packaging and distribution. • Operations on different products should not be carried out simultaneously or consecutively in the same room or area unless there is no risk of mix-up or crosscontamination. its strength (where applicable) and the batch number. • At all times during processing. with the involvement of the quality control department. with the objective of obtaining products of the requisite quality. this indication should also mention the stage of production. quarantine.
particles. and from operators’ clothing. This risk of accidental cross-contamination arises from the uncontrolled release of dust. cross-contamination or mix-up).• In-process controls are usually performed within the production area. • Contamination of a starting material or of a product by another material or product must be avoided. from intruding insects. sprays or organisms from materials and products in process. etc. skin. • Cross-contamination should be avoided by taking appropriate technical or organizational measures 61 .g. from residues on equipment. vapours. The performance of such in-process controls should not have any negative effect on the quality of the product or another product (e. gases.
intermediate products. packaging materials. nor products released for sale or supply. trained personnel and approved procedures must be available for sampling. and where appropriate for monitoring environmental conditions for GMP purposes. • Adequate resources must be available to ensure that all the quality control arrangements are effectively and reliably carried out. and finished products. until their quality has been judged to be satisfactory. specifications and testing. inspecting. inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated. 62 . Each manufacturer (the holder of a manufacturing authorization) should have a quality control function. 2. The basic requirements for quality control are as follows:-1. who has one or several control laboratories at his or her disposal. samples of starting materials. and with the organization.GOOD PRACTICES IN QUALITY CONTROL Quality control is the part of GMP concerned with sampling. Quality control is not confined to laboratory operations but must be involved in all decisions concerning the quality of the product. The quality control function should be independent of other departments and under the authority of a person with appropriate qualifications and experience. bulk products and finished products must be taken by methods and personnel approved of by the quality control department. qualification and validation must be performed. adequate facilities. and intermediate. documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use. bulk. records must be made (manually and/or by recording instruments) demonstrating that all the required sampling. • • The independence of quality control from production is considered fundamental. and testing starting materials. 4. 3. packaging materials.
records must be made of the results of inspecting and testing the materials and intermediate. the retained product must be kept in its final pack unless the pack is exceptionally large. such as to establish. to ensure the correct labelling of containers of materials and products.5. in their proper container and correctly labelled. • Quality control as a whole will also have other duties. 6. the ingredients must be of the required purity. 8. validate and implement all quality control procedures. no batch of product is to be released for sale or supply prior to certification by the authorized person(s) that it is in accordance with the requirements of the marketing authorization. In certain countries. maintain. and store the reference standards for substances. bulk and finished products against specifications. recorded. by law. and to participate in environmental monitoring. to participate in the investigation of complaints related to the quality of the product. CERTIFICATES Certificates must contain at least the following information:-• identification (name and address) of the issuing supplier. to ensure that the stability of the active pharmaceutical ingredients and products is monitored. 7. All these operations should be carried out in accordance with written procedures and. the finished products must contain ingredients complying with the qualitative and quantitative composition of the product described in the marketing authorization. product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures. to evaluate. 63 . sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary. where necessary. the batch release is a task of the authorized person from production together with the authorized person from quality control.
64 .• • • • • • signature of the competent official. the date of testing. and statement of his or her qualifications. the name of the material tested. the batch number of the material tested. the test results obtained. the specifications and methods used.
Each organization should develop its own quality management system in order to adhere to ISO 9001 guidelines. One such universal standard that applies to all types of organizations is ISO 9001. The second such audit is conducted by the customers using the product or service in question. 65 . and the third audit is conducted by the organization that is authorized to grant ISO certifications for quality maintenance. The first audit is conducted by the quality monitoring and inspection professional from within the organization i. ISO 90012000. What Is ISO 9001 ISO stands for International Organization for Standardization. To get ISO 9001 certification.e. ISO standards for quality are recognized worldwide and hence ISO certified organizations have far better opportunities to trade in the international market. whether it is service or manufacturing industry. This certification enhances the brand value of the organization.. its products or services and it also instills confidence in the customers. The latest edition of the standard is ISO 90012008. Big as well as small businesses adopt these quality standards worldwide and get certification after audit from the authorized body that ensures the company and its manufacturing or service delivery steps and procedures are in compliance with the laid down standards and polices.e. ISO 9001. the organization has to undergo three audits. Benefits Of ISO 9001 2008 The ISO 9001 standard was first published in 1987.QUALITY ASSURANCE STANDARDS Quality Assurance Standard for ISO 9001 Quality assurance standard is a written set of instructions and guidelines followed by various industries in order to maintain the quality of their products or services. quality assurance standard can be followed by any kind of industry. which was released in December 2008. Some QA standard documents are industry specific while some apply to all organizations. This edition has minor changes as compared to the earlier one i. internal auditor.
and procedures in the organizations to do each and every task. Hence. There are defined systems. Customer Satisfaction The customers trust the organizations that are ISO 9001 certified because this QA standard certification offers a sort or an assurance of the good practices and systems in organizations. their loyalty towards the organization increases. 66 . All this helps the organization to reduce wastage and increase margins. Teams are designated to perform these tasks. This leads to improved quality and less rework. When customers get good products or services in accordance to their requirements.Systematic Approach The standard helps the organizations to function in a more systematic manner. processes. it results in more organized and systematic approach to work which improves employee satisfaction and retention Improved Quality The systems are integrated in the whole organization to deliver good quality products or services. This results in more business for the organization. The profits of the organization also increase.
profitability and market shares. competitiveness and customer satisfaction. • Finally. 67 . increase in corporate performance and productivity. strongest defence against competition and the only path to Sustained company growth and earnings.CONCLUSION In evaluating data gathered and systematic analysis of the reports in the course of the study regarding the impact of QUALITY ASSURANCE on corporate performance and productivity in the Arch Vitalife laboratories. • Though. as this can help change the entire process and maintain the competitive edge which the company seeks to attain. • Involvement of all members of the company in the system is crucial if improvement in the performance and productivity is ever to be achieved with the adoption of QUALITY ASSURANCE. the following conclusion can be drawn: -• There are signs that QUALITY ASSURANCE concepts improves the performance of an organization in terms of cost reduction. the importance of QUALITY ASSURANCE in achieving business success can hardly be denied Quality is therefore the best assurance of customer allegiance. there must be consistency in the system. making the customer delighted as well as staff and in achieving corporate goals and objectives. • The concept of QUALITY ASSURANCE has been highly welcomed in the company as a way of life for customer satisfaction. this is not easy to achieve but it must come from personal example and commitment. In addition.
As long as there are new ideas.RECOMMENDATIONS Based on the research findings and the above conclusion. • There is need for top management to be more committed to QUALITY ASSURANCE. on the impact of QUALITY ASSURANCE on corporate performance and productivity. there should be reasonable focus in setting strategic objectives and building organizational routing that link many units and levels as much as possible. Similarly. skills and prepare them for future challenges The benefits of QUALITY ASSURANCE should not be over stated . there should be no end to QUALITY ASSURANCE process. This can be done by providing regular staff training programmes for the staffs as this will help increase their knowledge. Hence. • The QA approach to any process should be based on the requirements of external customers for the sake of their satisfaction because if the QUALITY 68 . there should be QUALITY ASSURANCE awareness campaign a well as QUALITY ASSURANCE meetings where programmes/ideas can always be discussed. the following are highly recommended towards improving QUALITY ASSURANCE in the sector: • The practice of QUALITY ASSURANCE should be regarded as an activity. • The company should intensify efforts on cost reduction exercise. developments. so as to be able to cope with the dynamism of the modern world. rather the whole quality effort should be dedicated to and judged by predetermined results. And there should be no organizational barriers between departments and managerial operational procedure within the company. innovations. as well as providing an enabling environment to incorporate all within the system in the QUALITY ASSURANCE process.
This is what adds to product and quality services. Success requires the company literally builds customers needs and expectations (including meeting of these needs and expectation) into daily organizational routines with the aim of enhancing corporate performance and increase productivity in the market. • Internalization of QUALITY ASSURANCE strategies is also the recipes that provide long-term approach to improving shareholders value by ensuring corporate survival and growth. • Finally. that it is not just implementation of QUALITY ASSURANCE that matters. • It must also be borne in mind. It is only those that maximize quality to their customers while at the same time meeting the needs of its staffs that will succeed. and operations should bear in mind that success only comes to firms that can fully internalize and adopt QUALITY ASSURANCE strategies to their own business environment. The recipes for success require enhanced organizational staff cooperation for improved customers/clients satisfaction. the concept will fail. structure. management of organizations.ASSURANCE activities are not geared towards customers’ satisfaction. 69 . reduces or increases revenue. irrespective of size.
B. “Quality Control” WEBSITES • • • • www.com http://www.com www. Besterfield. south western Dale H. "Juran's Quality Handbook".References BOOKS • • • • Godfrey. Tokyo: Asian Productivity Organization James & james.asq. 2001 “Total quality”.qualityassurancemag. A.. 1999 Ishikawa.com 70 .Guide to Quality Control.org/ www. 1982. Kaoru.quality-assurance-solution.archvitalife.
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