A Literature Review of Design and Manufacturing of a Product

Quality in Pharmaceutical Industry – Literature Review

Posted On April 22, 2016

Quality in the Pharmaceutical Industry – A Literature Review

Hither is a Literature Review on the topic of Quality in the Pharmaceutical Industry. It is not specific to Quality by Design (QbD) or (Process Analytical Technology) PAT. However the literature review does accept a small section on both QbD and PAT. If you are looking for a list of publications specific to QbD and PAT, you lot can become hither.

Reham M. Haleem , Maissa Y. Salem, Faten A. Fatahallah, Laila E. Abdelfattah of Rex Saud University shares their literature review in the topic of quality in the pharma industry.

This commodity serves as a good primer to the topic of quality concepts mentioned in the pharmaceutical industry. They do look outside the pharmaceutical industry since quality movement has been more popular in other industries such every bit automotive, aerospace and electronics.

(posted with permission, open up admission funded by King Saud University, under a creative eatables license.)

Abstract

Objectives

The aim of this study is to:

Highlight the most of import guidelines and practices of quality in the pharmaceutical industry.
Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices.

Design

A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the full general quality practices. The content of those sources was analyzed and the following themes were identified:

Research theme ane: Guidelines of the pharmaceutical quality.
Research theme 2: General practices recently practical in the pharmaceutical industry.

Master outcome measures

The following guidelines were identified and reviewed in the research theme I.:

WHO guidelines,
FDA guidelines,
European union guidelines and
ICH guidelines

In enquiry theme Ii; the following topics were identified and reviewed:

quality risk management,
quality by blueprint,
cosmetic actions and preventive actions,
process capability analysis,
Six Sigma,
process belittling technology,
lean manufacturing,
full quality direction,
ISO series and HACCP.

Results

Upon reviewing the previously highlighted guidelines and the practices that are widely practical in the pharmaceutical industry, information technology was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices just the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices.

Conclusions

Information technology is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be washed to prove the feasibility of such practices.

Keywords

Quality; Pharmaceutical industry; GXPs

1. Introduction

The quality in the pharmaceutical industry has get a very important topic. Since the world has gathered together to harmonize its practices and guides and the launching of the FDA current good manufacturing practices – the cGMP; for the 21st century – there has been a growing sensation for the significance of the quality of the pharmaceutical products ( Woodcock, 2004 ).

This awareness is represented through the advent of several definitions defining exactly what the quality of the medicine should be ( LEE and Webb, 2009 ). Many manufactures were written to demonstrate the special nature of the production-customer relationship of medicine and patients ( Woodcock, 2004 ).

Besides the important role of governments was emphasized through the joint statement between the international pharmaceutical federation; FIP; and the international federation of pharmaceutical manufacturers associations; IFPMA; to ensure the safety of medicinal products in society to protect the patient ( FIP Quango, 1999 ), providing that the pharmaceutical industry is one of the about closely regulated industries for more than 50 years ( Woodcock, 2004 ).

Since 2002, FDA began an initiative to address cGMP for the 21st century ( Woodcock, 2004 ). This effort involved taking new looks at both the regulatory and industrial systems for insuring drug quality (Larson, 2006).

A literature review was conducted on the quality in the pharmaceutical industry, identifying 102 publications that focus on conceptual issues, methodological problems, or the application of different practices and/or guidelines practical in the pharmaceutical industries. The content of these sources was analyzed, and a number of themes were identified.

The literature review has two objectives concerned with the quality guidelines and practices of the pharmaceutical manufacture and the system such as practices and guidelines to make a guide for others to utilise.

A research of this kind serves to integrate past research and tin aid current and futurity researchers, and practitioners employing the suitable guideline or practice to develop their methodological decisions in upgrading the industry.

This article introduced some issues regarding what is so special most pharmaceutical quality and dissimilar drivers of quality are and then identified ( Fraser, 2005 and Dean and Bruttin, 2001 ). This is followed by the identified enquiry themes and their development. Finally, managerial implications are discussed.

2. Methods

A search was made of the following databases: WHO, FDA, ICH, and Eu to download their corresponding guidelines. Using the Google search engine; besides a number of papers and manufactures were downloaded. Search words used were: pharmaceutical quality, quality and pharmaceutical industry. Papers that were not academic in nature were rejected (for instance, those that did not provide reference citations).

The final sample consisted of 102 publications; 56 publications were related to the pharmaceutical quality direct while 46 publications were concerned with the full general quality practices.

Two research themes could be identified in the articles studied in this literature review.

They included:

Guidelines of the pharmaceutical quality.
General practices recently applied in the pharmaceutical industry.

For each of these research themes the authors synthesize the principal findings and offer suggestions for further research.

ii.1. Inquiry theme 1: guidelines of the pharmaceutical quality

The most of import guidelines that are widely practical in the pharmaceutical manufacture are:

ii.one.i. WHO guidelines

WHO has published a handbook on the GMP in particular, entitled: Quality assurance of pharmaceuticals, a compendium of guidelines and related materials, Volume ii: good manufacturing practices and inspection ( Quality Assurance of Pharmaceuticals, 2004 ).

It consists of 4 chapters:

Chapter ane: WHO GMP: main principles for pharmaceutical products.

Affiliate two: Good manufacturing practices: starting materials.

Chapter 3: Good manufacturing practices: specific pharmaceutical products.

Chapter 4: Inspection.

And 7 annexes:

Annex 3: Radiopharmaceutical products.

Annex iv: Skillful manufacturing practices for pharmaceutical products: master principles.

Annex v: Model Certificate of GMP.

Annex 6: Sterile pharmaceutical products.

Annex 6: Guidance on GMP inspection.

Annex 7: Pre-blessing inspection.

Annex 8: Quality system requirements for national GMP inspectorates.

2.1.2. FDA guidelines

Pharmaceutical manufacturers have just begun to sympathize and use the FDA's cGMPs for the 21st century: A Run a risk-Based Approach; the initiative outlines firsthand, near and longer-term stages that FDA believes will take two years to be implemented ( Larson 2004 ).

On the technical side, FDA states iii concepts that volition guide the reevaluation procedure: advances in risk management scientific discipline, advances in quality management scientific discipline and advances in pharmaceutical scientific discipline and manufacturing applied science ( Larson, 2004 ).

The nearly of import guidelines are 21 CFR Part 210, 2005 and 21CFR Part 211, 2005 .

21CFR Part 210: The regulations contain the minimum current skillful manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or belongings of a drug to clinch that such a drug meets the requirements of the act as to prophylactic, and has the identity and strength and meets the quality and purity characteristics that information technology claims to possess.

21CFR Role 211: The regulations in this office contain the minimum electric current proficient manufacturing practice for preparation of drug products for administration to humans or animals.

The FDA has ended that modern quality systems together with manufacturing processes and product knowledge, can handle many types of changes to facilities, equipment and processes without the demand for regulatory submission ( Fraser, 2005 ).

two.1.3. EU guidelines

The cadre of Eu legislation in the pharmaceutical sector is gathered in Volume ane and Volume 5 of the publication; " The rules governing medicinal products in the European Spousal relationship ".

Volume 1 – EU pharmaceutical legislation for medicinal products for man use.
Book 5 – Eu pharmaceutical legislation for medicinal products for veterinary apply.

The bones legislation is supported by a series of guidelines that are too published in the following volumes of " The rules governing medicinal products in the Eu ":

Volume ii – Find to applicants and regulatory guidelines for medicinal products for human use.
Volume 3 – Scientific guidelines for medicinal products for human being use.
Book iv – Guidelines for good manufacturing practices for medicinal products for human and veterinary utilize.
Volume 6 – Notice to applicants and regulatory guidelines for medicinal products for veterinary use.
Volume vii – Scientific guidelines for medicinal products for veterinary use.
Volume 8 – Maximum residual limits.
Volume 9 – Guidelines for pharmacovigilance for medicinal products for human and veterinary use.
Volume 10 – Guidelines for clinical trial.

two.ane.four. ICH guidelines

The International Briefing on Harmonization of technical requirements for registration of pharmaceuticals for human being use (ICH) is a special projection that gathers the regulatory government of Europe, Japan and the United states and experts from the pharmaceutical industry in the three different regions; to discuss scientific and technical aspects of product registration.

The objective of such harmonization is a more efficient utilise of human, brute and material resources, and the removal of any delay that is not essential in the global evolution and availability of new medicines while maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.

2.2. Inquiry theme 2: full general practices recently applied in the pharmaceutical industry

2.2.one. Quality risk management

All products and all processes have an inherent element of hazard ( Griffith, 2004 ).

In an organization that is intending to apply an constructive quality chance management arroyo, a clear definition of what is considered "risk" should be agreed upon because of the too many stakeholders in the pharmaceutical industry and their corresponding various interests ( ICH Q9, 2003 ).

The FDA has noticed that it needs to reorganize its procedures and processes to merge the use of risk management programs (RMP) inside the agency and within the industries it regulates. Consequently, the FDA has started publishing position papers and guidelines on what information technology expects to see in an RMP ( Griffith, 2004 ).

Risk management plans should be used to place take chances ( Griffith 2004 ).

Quality Adventure Management is defined as a method for the assessment, control, advice and review of risks to the quality of the drug (medicinal) product through the product lifecycle where decisions can occur at whatsoever signal in the procedure ( ICH Q9, 2003 ).

In the guideline entitled Medical Device Use-Safety: incorporating human being factors engineering into hazard management; it clarifies how hazards related to medical device use should be directed during device development as part of the risk management process ( CDRH, 2000 ).

2.2.ii. Quality past design

ICH Q8 defines design space from the concept that quality cannot be tested into product but has to be congenital in by pattern ( ICH Q8, 2005–2008 ).

Based on the ICH Q8; which concerns pharmaceutical evolution with targeting designing quality into the ingredients, conception and manufacturing process to deliver the intended performance of the product. Design space is presented by the applicant and is field of study to regulatory assessment and approving ( ICH Q8, 2005–2008 ).

In these situations, opportunities exist to develop more flexible regulatory approaches.

The design and deport of pharmaceutical development research should exist consistent with their intended scientific purpose ( ICH Q8, 2005–2008 ).

two.ii.3. Corrective action and preventive actions

QMS nonconformities and other system deficiencies, including legal noncompliance, should be analyzed to detect patterns or trends. Identifying trends allows the manufacturer to anticipate and prevent future problems ( EPA, 2009 ).

The organization should focus on correcting and preventing problems. Preventing problems is mostly cheaper than fixing them after they occur. The system should also offset thinking about problems as opportunities to improve ( EPA, 2009 ).

"Root cause analysis" is a process past which the manufacturer tin identify causes and preventive deportment ( EPA, 2009 ).

In general, CAPA experts recommend that root-cause investigations follow a four-stride process ( Bartholomew, 2006 ):

Identify the problem.
Evaluate its magnitude, which includes assessing risk.
Investigate and assign responsibility.
Analyze and certificate the root cause of the problem.

For example a new cosmetic activeness tracking system had helped Alcon Laboratories Inc. unite its many corrective and preventive action systems worldwide resulting in faster time of closure on corrective action, both access and speed to data are much greater and finally quality professionals are able to focus on more important bug ( Davis, 2003 ).

2.two.4. Process capability analysis

Process adequacy is the comparison of the "Phonation of the Customer" (VOC) with the "Voice of the Process" (VOP). VOC, which is built on client requirements, is defined by the specification limits of the process, which are fixed, while VOP is divers by command limits, which are based on functioning data and vary over time ( Tarpley, 2004 ).

Metrics such every bit adequacy index namely Cp and Cpk were developed several years ago to calculate this comparing betwixt control and specification limits ( Tarpley, 2004 ).

The capability alphabetize a ratio that compares process spread to tolerance spread and results in a single number. It is a direction tool which is used to compare process functioning ( Ruth Two, 2005 ).

2.2.5. Six Sigma

Harry and Schroeder (2000) ascertain Six Sigma as "…a business process that enables companies to increase profits dramatically by streamlining operations, improving quality, and eliminating defects or mistakes in everything a company does…." It can assist an organisation reduce defects and improve profitability using several bones tenets (Harry and Schroeder, 2000; Johnson and Swisher, 2003; Pande et al., 2000; Williams 2003; Goeke and Offodile, 2005 )

Six Sigma Projects are based on the DMAIC model ( Stamatis, 2002 ).

The DMAIC model is the generic model of six sigma methodology. It is an acronym that stands for; Define, Measure, Clarify, Improve and Command. Sometimes this model includes recognize as an awareness item to the model. Each of the components addresses a unlike aspect of the overall improvement and breakthrough strategy ( Stamatis, 2002 ).

The pharmaceutical manufacture sigma level is from 2 to 3; this results in a 25–35% defects ( Hussain, 2005 ).

An case of the pharmaceutical firms that adopted the methodology of 6 Sigma is AstraZeneca where the operations and quality staff were trained to employ DMAIC principles every twenty-four hours, to measure and improve functioning through cross-functional "continuous improvement" (CI) teams ( Shanley, 2005 ). Two years ago, at Westborough, Massachusetts, cross-functional CI teams involving QA, engineering and operations applied DMAIC principles to solve a major chapters problem for a key product. The teams discovered wasteful processes, effectively adding xx one thousand thousand actress units of chapters per year. Where a capital letter investment of less than $100,000 led to $sixty 1000000 to $70 meg in revenue gains, without hiring new staff as Ron Matthews, vice president of manufacturing and supply chain at the company, said ( Shanley, 2005 ).

2.2.6. Procedure analytical technologies

Process analytical technologies (PAT); play a key role in enabling "quality by design" and scientific attribute of manufacturing. PAT's master aim is to empathize and control the manufacturing process through the application of integrated chemical, concrete, microbiological, mathematical and adventure analysis methods. PAT has been applied in non-Pharma industries for many years, yielding cost savings and manufacturing efficiencies ( Fraser, 2005 ).

The implementation of process analytical technology (PAT) is bringing lots of benefits and improvements for many pharmaceutical processes. The benefits are lower production wheel times, improved manufacturing efficiency, reduced rejects and increased production operating time ( Rockwell Automation, 2004 ).

Inside pharmaceutical industry, there take been a number of successful PAT-based comparability protocol submissions, ranging from single-unit operation application at GlaxoSmithKline to a more all-including awarding covering both drug substance and drug product at Sanofi-Aventis ( Shanley, 2005 ).

two.2.7. Lean manufacturing

Japanese manufacturers re-building after the Second World War were facing declining homo, cloth, and fiscal resources. These circumstances led to the development of new, lower cost, manufacturing practices. Early Japanese leaders such equally the Toyota Motor Company'south Eiji Toyoda, Taiichi Ohno, and Shingeo Shingo adult a disciplined, procedure-focused production organisation now known every bit the "Toyota Production System", or "lean production." The objective of this system was to minimize the consumption of resources that added no value to a product ( Womack et al., 1990 ).

Lean manufacturing is well-nigh eliminating waste material across an entire company and focusing on the big picture through learning how to do more with less ( Nystuen, 2002 ).

Lean ways putting the correct things in the right place at the right time the first time while minimizing waste product and being open up to change. This leads to less waste product, less design fourth dimension, fewer organizational layers, and fewer suppliers with more employee empowerment, more flexibility and adequacy, more productivity, more than customer satisfaction and without a incertitude, more long-term competitive success. Lean principles incorporated in the workplace today tin spell business organisation survival for the hereafter ( Nave, 2002 ).

In AstraZeneca; rather than being submerged into Lean, the company launched a limited initiative at its global facilities in 2002 which is the Pull Manufacturing; this initiative required that the company's manufacturing teams shift their focus from output to customer alignment and service. Likewise, the initiative has atomic number 82 to reduction in the bicycle time. In one case, information technology allowed lead fourth dimension for a primal $1.5-billion-per year product to be reduced by 25% during a catamenia when demand for the drug was increasing past xxx% ( Shanley, 2005 ) (see Table 1 ).

Tabular array one.

ICH categories and master topics.

Q: Quality Topics

Those relating to chemical and pharmaceutical Quality Balls:

Stability
Analytical Validation
Impurities
Pharmacopoeias
Quality of Biotechnological Products
Specifications
Skillful Manufacturing Do
Pharmaceutical Development
Run a risk Direction

S: Rubber Topics

Those relating to in vitro and in vivo pre-clinical studies
Carcinogenicity Studies
Genotoxicity Studies
Toxicokinetics and Pharmacokinetics
Toxicity Testing
Reproductive Toxicology
Biotechnological Products
Pharmacology Studies
Immuno-toxicology Studies
Joint Safety/Efficacy (Multidisciplinary) Topic

E: Efficiency Topics

Those relating to clinical studies in man subject

Clinical Safe
Clinical Study Reports
Dose-Response Studies
Ethnic Factors
Good Clinical Practice
Clinical Trials
Guidelines for Clinical Evaluation by Therapeutic Category
Clinical Evaluation

M: Multidisciplinary Topics

They are Cross-cutting topics, which practise non fit uniquely into one of the to a higher place categories.

M1: Medical Terminology (MedDRA) ⁎
M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)
M3: Timing of Pre-clinical Studies in Relation to Clinical Trials
M4: The Mutual Technical Document (CTD)
M5: Data Elements and Standards for Drug Dictionaries

⁎Medical Dictionary for Regulatory Activities Terminology.

Eli Lilly had suffered factory losses – process barely capable with some nonconformance and variability in production quality, the application of lean lead to system improvement and cost savings as shown in the following Table two ( Mohan, 2006 ).

Tabular array 2.

The cost of system improvements in Lilly.

Control system improvement	% Of savings gained	% Of overall cost of control system
Implementation of regulatory control systems and basic hardware	xx	70
The use of advanced control procedures such as feed forrad and model based	75	80
The application of optimization methods to the procedure	100	100

2.2.8. Total quality management

Total quality management (TQM) is a concept rather than a technique. It is a philosophy that stresses a systematic, integrated, and consistent perspective that would involve everyone and everything in the organisation ( Isaac et al., 2004 ).

TQM is a management philosophy that builds a customer driven, learning organization that is devoted to the total client satisfaction through continuous improvement in the effectiveness and efficiency of the system and its corresponding processes ( Corrigan, 1995 ).

TQM is widely known for improving quality and other performances such equally productivity, profit, marketplace share, and competitive edge of organizations of various types (Sun, 2000; Isaac et al., 2004 ).

2.ii.9. ISO serial

ISO 9000 series: ISO 9000 is concerned with "quality management". This ways what the organization does to increment customer satisfaction through meeting client and regulatory requirements and continually improving its performance ( ISO 9000 and 14001 in brief, 2009 ).

ISO 14000: ISO 14000 is an environmental direction system, describes the requirements for an system's environmental management organisation and can be used for certification/registration and/or self declaration of an arrangement's environmental management system ( ISO 14001, 2004 ).

This ways what the system does to ( ISO 9000 and 14001 in brief, 2009 ):

Minimize harmful effects on the environment caused by its activities.
Attain continual improvement of its environmental performance.

ISO 17025: Information technology gives the general requirements for the competence of testing and calibration laboratories ( ISO/IEC 17025, 2005 ).

A specific version of this standard for Medical Laboratories has been adult; ISO 15189:2003 then ISO 15189, 2007 was published on 19th Apr 2007 ( ISO 15189, 2007 ).

Through the accreditation procedure; the testing laboratory reaches the status of an independent institution ( Mettler-Toledo GmbH, 2003 ).

2.2.10. HACCP

The Hazard Analysis and Critical Control Point (HACCP) methodology was known to be a rubber management system used in the food industry. Their main aim is to preclude known hazards and to reduce the risks that they will crusade at specific points in the food chain (Annex 7; WHO TRS No. 908, 2003 ).

Procedures, including GMP, address operational conditions and provide the ground for HACCP. HACCP is a systematic method for the identification, cess and command of safety hazards. The hazards are classified as biological, chemical, or concrete agents or operations that might cause illness or injury if not controlled. In the industry of pharmaceuticals, this includes the manufacture of certain antibiotics, hormones, cytotoxic substances or other highly active pharmaceuticals. Together with operations such as fluid bed drying, granulation is an example of adventure unit operations. The use of inflammable solvents (solutions) and certain laboratory operations may likewise produce hazards (Annex seven; WHO TRS No. 908, 2003 ).

The HACCP system is based on 7 principles (Addendum 7; WHO TRS No. 908, 2003 ):

Conduct a hazard analysis.
Determine the critical control points (CCPs).
Establish target levels and critical limit(due south).
Establish a system to monitor the CCPs.
Establish the corrective activeness to be taken when monitoring indicates that a particular CCP is not under control.
Found procedures to verify that the HACCP system is working effectively.
Establish documentation concerning all procedures and continue records advisable to these principles and their application.

3. Results

Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an arable number of papers and articles that explicate the full general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices.

4. Discussions

It is recommended that the literature would invest more in the expanse of application and significance of guidelines and practices.

Likewise, there are some new practices that are recently applied to the pharmaceutical industry though they are widely applied in non pharmaceutical industries, such as: the lean manufacturing; the Six Sigma; the total quality direction. Both managers at the pharmaceutical industry and literature should focus on the adoption of such practices into the pharmaceutical industry making use of the previous research in the non-pharmaceutical industry application. New case studies should exist done to prove the feasibility of such practices.

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PDF paper is here ( source: doi:ten.1016/j.jsps.2013.xi.004)

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