The sixth international employment survey reports on the issues directly related to those working in the pharmaceutical industry, including demographic information, education and work experience, salary and benefits, and attitudes toward current employment. In addition, survey participants were asked to indicate the importance of particular educational backgrounds and skills when evaluating new employment candidates. Results are provided for employees working in the US, including Puerto Rico, and those working in Europe. Industry workers located in other countries also participated in the survey; however, only responses from those working in Canada were of sufficient number (27) to calculate an average base annual salary. 	

When comparing salary and benefits information, readers should take into account factors such as a region's cost of living, economy and exchange rate to US currency (respondents were asked to indicate all salary information in US$). In addition, readers are encouraged to take into account geographic location, years of experience, job function and highest level of educational certification. No single statistic should be used for comparison without taking these factors into account. 	

The questionnaire was posted on the Internet (www.pharmtech.com) from 1 August to 30 September 2003. Results were exported and separated according to the respondents' geographic region of employment (US, including Puerto Rico, or Europe). A total of 1619 responses were received. Of these, 1251 were from pharmaceutical employees working in the US, 262 were from those working in Europe and 106 were from other regions. Table I lists some of the overall findings reported by US and European employees. This article describes these and other results in detail. 	

Table I:  Profile of the typical pharmaceutical industry employee working in the US and in Europe.				

Results are presented as mean average values or as percentages of the total number of respondents to a particular question (denoted as n). This article is also available online at www.pharmtech.com. The editors encourage readers to submit comments about this year's survey as well as suggestions for next year's questionnaire.	

Gender. Of 1501 total responses to this question, 69% were from men and 31% were from women. Figure 1 shows that the pharmaceutical workforce consists mostly of men by a 2:1 ratio in the US and at least a 4:1 ratio in Europe.				

Age. The average age of an industry employee working in the US or in Europe is 42 years. This result remains unchanged from previous surveys. 		

Figure 1:  Gender demographics for the US and Europe and Figure 2:  Pharmaceutical employees' formal education.	

Work location. Of 249 respondents working in Europe, 71 (28%) work in the UK. The number of responses received from those working in other European nations was as follows:	

In addition, 27 respondents indicated that they work in Canada. As previously stated, 1251 responses were received from those working in the US. Again, readers should be aware of the number of responses received (sample size) from each region when  noting the results of this survey, including reported salary results.	

Education and professional work experience 

Figure 2 shows that a higher percentage of European pharmaceutical employees earned a formal education beyond a bachelor's degree than did their US colleagues. Forty nine per cent (n51244) of all respondents working in the US reported completing their formal education at a bachelor's degree level, compared with 26% (n5251) of European respondents. Nearly one third (31%) of European respondents completed a doctorate degree, compared with 22% of US respondents.			

The most common field of study for US respondents was analytical chemistry. Fourteen per cent of US respondents reported it as their major field of study. For European respondents, pharmaceutics or pharmacy was the most studied academic topic. Twenty one percent of those working in Europe earned their highest qualification in this field. A significant number of respondents (23% US and 9% European) reported that their highest qualification was in a field other than those listed in the questionnaire. Of these, most were in biotechnology-, biology- or chemistry-related areas, and several respondents indicated they had earned doubled majors. Industry employees in the US and Europe reported an average of 16.4 and 18.0 years of professional work experience, respectively, including postdoctoral study. 	

Type of employer. A preponderance of US and European respondents are employed in private industry (89% for each group). Those employed in academia represented 4% of European respondents and only 3% of US respondents. The remaining participants were employed in either local or national government. Thus, the information provided in this article, including salary and attitudes toward current employment, clearly best represents those working in the private sector.				

Figure 3:  Annual salaries according to geographic region and Figure 4:  Salary according to gender.				

Employees in academia. Of the 78 American and 22 European responses from those working in academic institutions, 17 in the US and nine in Europe hold the position of either full, associate or assistant professor. Most of those employed in academia hold no administrative title and are neither a department head nor dean.	

Employees in government or private industry. Out of 1124 private industry employees working in the US, 82% work in pharmaceuticals as opposed to working in contract services, diagnostics, equipment, non-manufacturing areas or excipients/chemicals. Similarly, 84% of private industry employees in Europe indicated that they work in pharmaceuticals (n5230). Although the survey received only 36 responses from those working in US government, 21 indicated that they work in pharmaceuticals. Similarly, the two responses received from those working in European government indicated they also work in the pharmaceutical sector. 					

"Given the opportunity, I would leave my current job" and "I believe my present job is secure."	

Job description. The sidebar "Top five job functions" lists the most common job descriptions. As in the past 5 years, quality control/quality assurance (QA/QC) was the most common field of expertise (18 and 20%, US and Europe, respectively), and pharmaceutical development was the second most common field of work (13 and 12%, respectively). Ten per cent of US respondents work in pharmaceutical analytical development, 8% work in engineering or engineering management and 6% work in validation. For European respondents, engineering/engineering management (7%), biopharmaceuticals (5%) and consultant services (5%) rounded out the top five. 	

US and European pharmaceutical employees continue to share similar employment environments. Ninety seven per cent of US respondents and 96% of European respondents are employed full-time. On average, US and European employees are contracted to work 40 and 38 h per week, respectively, but actually work more than 46 and 45 h per week, respectively. Ninety one per cent of US and 85% of European employees indicated that they do not receive financial reimbursement for the extra hours worked. 		

Figure 5:  Annual salaries according to job function.	

On average, US employees have worked for their current employer for 6.8 years. European respondents reported an average number of 10.6 years with their current employer. However, for the first time, results revealed that the majority of respondents in the US (53%) have changed their job title during the past 2 years. A majority (64%) of these changes was not the result of mergers, acquisitions or downsizing. Most (58%) employees in Europe have not changed their title or company affiliation during the past 2 years. Of those who did indicate a change, 75% said the change did not result from a merger, acquisition or company downsizing. 	

Overall results. The mean base annual salary of those employed in the US was $84477 (n51197), which is approximately a 2.8% increase compared with last year's average of $82163. Although this increase is notably lower than the 4.5–5.9% annual increases between 1999–2002, it is well in tune with the 2.5% average increase recently reported by the US Department of Labor for 2003. This base annual salary does not include bonuses, overtime, salary from a secondary job or other supplemental income. Employees in the US reported an average additional income from their principal employer of $8689, including bonuses, summer work and grants, and an average additional income from other professional work of $1448. 	

"In my present job, I use my skills and training to the fullest extent" and "Top reasons why I would change jobs"				

The mean base annual salary for those employed in Europe was $70131 (n5234), which is an increase of more than 17% compared with last year's reported value of $59918. This increase is the largest reported since 2000 and does not include bonuses, overtime, salary from a secondary job or other supplemental income. Employees in Europe reported an average additional income from their principal employer of $10189 (also an increase from last year's value of $6263), including bonuses, summer work and grants, and an average additional income from other professional work of $158. 	

Salary according to location. Figure 3 shows annual salaries according to the geographic region of employment. For the first time, the average salary of respondents working in Canada is included (n527). For respondents working in Europe, the range varies from an average of $104812 for those working in Switzerland to $23671 for those working in Eastern European countries. The reported average salaries from respondents working in nearly every European country, except those in Eastern Europe, were higher this year than those reported last year. However, it should also be taken into account that there were significantly fewer responses from employees in Europe than there were last year, so the mean values are less likely to be truly representative. 		

Figure 6:  Common benefits received by employees.	

Salary according to gender. Figure 4 shows that, on average, US women working full time earn 81% of the average salary reported by US men working full time. The gap between men's and women's salaries is slightly more than it was in last year's survey. This is also true for men and women working in Europe. On average, European women working full time earn 82% of the average salary reported by their male colleagues working full time. Interestingly, these values are approximately equal to the 79.8% value reported in the third quarter of 2003 by the US Department of Labor for other job markets. 	

Salary according to job function. Figure 5 shows the mean base annual salaries according to job function. The five highest paying jobs in the US were in consulting, production management, bulk pharmaceutical chemicals, drug delivery and technology transfer. Most fields in the US had an increase in their mean base annual salaries compared with last year. The highest paying job in Europe was in computer IS/IT, with an average salary of $86250, which is more than 45% higher than the reported average last year. Several job functions of those working in Europe provided annual base salaries in the mid $60–70000 range.			

Figure 7:  The average increase in annual salaries.	

Benefits. The most common benefits received both by US and European respondents are employer contribution toward their pensions and health insurance for themselves (Figure 6). Moreover, US respondents are granted an average of 14 days of paid holiday time during the calendar year but took only 12 of those days during 2002. European respondents were granted an average of 26 days of paid holiday time during the calendar year but took only 23 of those days during 2002.	

Articles

Features

Despite global economic problems during the last 2 years and continued industry-wide lay-offs in the manufacturing sector, the pharmaceutical industry workforce continues at a slow and steady pace. Employees, however, seem ever more wary of their job security.

Staying the Course: The Sixth Annual International Employment Survey

Pharmaceutical companies operate in a very sophisticated manner - innovation and quality are important elements. Workers in all areas - for example, scientists in discovery, formulation experts in development and analysts in manufacturing - work in close teams and enjoy the challenges they face. It is, therefore, very frustrating when, late in the development phase of a new drug candidate, the formulation starts to cause problems as it transfers to pilot production; or when an established production line faces continual delays because of the inconsistencies of powdered ingredients.	

In today's pressurized environment, there is a major drive to manufacture at lower cost. Some companies have responded by moving plants to developing areas that offer a lower cost base, such as Eastern Europe, India and South America. Others are looking to streamline existing facilities or outsource manufacturing to one of a growing number of third party specialist suppliers. Some pharmaceutical manufacturers are doing all three. In addition, initiatives to supply drugs for key global diseases (such as HIV/AIDS) at lower cost and patent expiry issues - with many blockbuster drugs losing ground to emerging generics - are impacting these decisions as well as adding to the overall competitive pressure.	

Figure 1:  The flow energy of hydrous lactose as a function of packing condition.	

The importance of powders and the need to measure

Almost all pharmaceutical products are in powder form at some point during their manufacture. The need to optimize formulation early (at laboratory and pilot scale) and the challenge of ensuring a smooth transition into full-scale manufacturing demand knowledge of the likely behaviour of the powdered components of a product. 				

Liquids, solids and gases are well characterized, and detailed information regarding their properties is well documented. Powders, however, are difficult to categorize, hard to describe and, in contrast to liquids, solids and gases, may be affected by a number of variables (for example, physical, chemical and, importantly, environmental). 	

This is logical because powders are a mixture of solid particles and air, and unlike other materials even a minor modification, such as simply moving a powder, can dramatically change its performance. Depending on the air content of a powder, rheological properties can typically change by a factor of 100 and in extreme cases by more than 1000 times (Figure 1).		

Figure 2:  Energy as a function of flow rate for various blends of lactose and magnesium stearate.	

Many scientists think of powders as inherently 'good' or 'bad' in terms of flow properties. But, in practice, a particular powder may flow very well under aerating conditions. Yet, after containment in a hopper, the same powder may be altered and have extremely poor flowability. If the same powder is exposed to moisture, its rheology, even under aerating conditions, can be poor. On the whole, flowability depends on how powders are handled and processed, which makes measuring them and predicting their behaviour a significant challenge.	

Traditionally, those who have tried to describe powder flow properties have used a single number; for example, angle of repose or shear strength. However, this approach does not reflect the complex nature of powders and the extent to which the rheological properties are affected by imposed environmental conditions such as flow rate, packing condition, humidity, temperature, charge, vibration and many other factors. For this reason, and against tradition, a range of parameters is needed to describe the flow properties of a powder. The idea that a single number can describe these complex materials is no more valid than it would be for people to be described simply by their age or height.	

A new approach, using a powder rheometer, gives sensitive and reproducible results, and can evaluate each of the many factors that affect powder flowability. A comprehensive profile of a powder is developed using just small amounts of material and the data generated add value at many stages of the development and production cycles. 			

Figure 3:  Wet granules of haloperidol being tested in a rheometer.				

Importantly, users have confirmed that this approach provides a real insight into increasingly important areas, such as how a formulation might interact with process machinery as it moves to scale-up and production. For example, magnesium stearate is commonly used as a die lubricant in tabletting. An investigation to determine its effect on the flow properties of spray-dried lactose was undertaken. Figure 2 shows how the flow energy measurement varies as a function of flow rate (blade tip speed) and the magnesium stearate content. The basic lactose sample with no additive exhibits the poorest flowability properties, with basic flowability energy and flow rate index being the highest of the test series. When 0.1% magnesium stearate was added, there were marginal improvements in flowability; but between 0.1–0.25%, there was a marked reduction in flow energy. Concentrations of magnesium stearate greater than 0.25% only had a small effect, suggesting that optimum flowability is achieved between 0.1–0.25%, where the resulting powder shows very good flow properties with a moderate basic flowability energy value and insensitivity to flow rate.	

Recent research has demonstrated how accurately predicting the end-point of a granulation step is essential to optimizing the final dosage form. Figure 3 shows a photograph of wet granules of haloperidol being tested in a rheometer during this work. Energy profiles indicated that at low water content, more energy is required when mixing for shorter times; and as water content increased to 12% w/w, the energy requirement increased with longer mixing times. By using a rheometer, it was possible to discriminate between samples that differed by less than 1% water content w/w. It was concluded that the ability to quantify the end-point in this way would allow operators to easily assess the granulation process. End-product quality has improved as a result.	

The need to understand in detail all aspects of a product and the processes that produce it has never been greater. Characterizing powders and powder flow is a small but significant area in which valuable improvements can be realized. It can impact many operations, such as in the early stages as a formulation is developed; matching materials to plant as a product transfers into full-scale manufacturing; and in ensuring the quality of raw materials, intermediates and final product. In addition, creating a database of standard flow characteristics of existing materials is assisting users to predict the impact of introducing a new material. In every case, failures, reworks and stoppages cause delays, cost money and adversely affect the bottom line, something that must be minimized.  

On the whole, flowability depends on how powders are handled and processed, which makes measuring them and predicting their behaviour a significant challenge.	

This article reflects on the challenges that predicting powder flowability currently pose to the pharmaceutical manufacturing industry and considers some of the benefits that can accrue when companies overcome these issues.

Predicting Flowability and Characterizing Powders

Every new year offers a moment to look briefly forwards and backwards; and, just before the end of last year, a happy chance wafted a document across this columnist's desk that provided some interesting festive season food for thought. It is a vision of the future of the European pharmaceutical industry - but a vision of the 21st century that comes from the past.	

So, to provide readers of this column with a sense of seasonal fun, you will have the opportunity to decide for yourselves to what extent the predictions were right or wrong. And as an esoteric pharmaceutical quiz, you can also have a guess at when the predictions were made and by whom. It contains plenty of clues and, in the spirit of seasonal goodwill, some of the answers appear at the end of this column. Some of the key passages from the document are presented below.	

"Let's look at what the pharmaceutical industry in Europe may be faced with after patent term restoration; after a European marketing authorization system has been set up; after the single market has 'harmonized' information and advertising; after some experience with transparency regarding pricing systems; and after some reshaping, perhaps, of the European political map and the political economy. Will the principal preoccupations have changed by 2000? Not profoundly, I think. The current wave of European legislative measures will have subsided, but in themselves these changes will have had a marginal rather than a fundamental influence."				

"Patent term restoration will certainly bring some relief for some products (but not many - and in most cases will only be effective from the beginning of the next century, when patents start to expire on the first products to benefit fully). It will, perhaps, have given some upward lift to research and development (R&D) investment confidence among the companies that depend most heavily on European sales."	

"But the perceived advantages for industry are likely to bring increasing calls from industry opponents (they have already begun) for tighter controls on industry, including controls on prices or on the allowable cost elements such as marketing or information; generic or therapeutic substitution; or intervention in the direction of research programmes and priorities . . ."	

"A European marketing authorization system may bring faster registration for some products, quicker pan-European access for more products, greater certainty concerning procedures and reduced costs in duplication of registration activity . . . But not all that much, and not all that soon. On the negative side, we will suffer some reduced flexibility regarding registration, and greater risks from increased parallel imports and the export of lowest prices to higher-priced countries . . . In addition, we are, in my opinion, going to see in any event a bigger part played by centralization, and the European Medicines Agency is one more step along this road. "	

"Increased transparency regarding national pricing systems may bring us some weapons to attack abuses - but how quickly they will work is a very open question. And at the same time, as a by-product of the transparency directive, the European Commission is steadily building up a network of centralized activities covering transfer pricing, therapeutic categories, national pricing and reimbursement systems - to say nothing of the data bank -- and whatever else may be introduced."	

"How different will our information and advertising practices be in 10 years time? Certainly there will be a greater degree of information and advertising coherence from country to country - but much of this will spring not so much from controls as from increased coherence of marketing authorizations and marketing strategies."				

"Where the biggest threat to industry self-determination may lie is perhaps that current efforts at control will lead later to the imposition of financial controls, ceilings of some sort on promotion or, worse still, a levy to finance some form of 'neutral' or 'independent' information. How far will other legislation continue to increase controls on our industry? There is no doubt that the environmental/consumer/social policy trend is still gathering strength. How far will it exact further costs from the pharmaceutical industry in Europe - in terms of cancelled research investment in threshold technologies, added costs of regulation of dubious value, or juridical uncertainty from conflicting regulation?"	

"More generally, are there likely to be dramatic changes in how health care spending and social security cover develop in Europe? Will Europe's economic dynamo generate enough energy to provide expensive medical technology in greater volume for the increasingly elderly population? And if spending does increase, how far will the pharmaceutical industry be able to demonstrate that its products, even when expensive, can provide net gains in health care spending? Or will economic growth lag behind and become swamped by greater demands for high-volume social provision? How far will the demand shift towards low-cost rather than high-value health care?"	

"How will the integration of eastern Europe into western Europe and the western world market economy affect conditions? Who is going to pay to raise health care standards in eastern Europe? It could mean bigger demands for pharmaceuticals, but who will supply them? And will demand be for generics or innovations? If, for instance, eastern European economies do grow, it is not only their demand for pharmaceuticals that will expand; so too, inevitably, will their production. How will that affect current suppliers? It's relatively easy to make a list of questions. What about some answers? Generally, I believe the fundamentals will remain the same: demand for pharmaceuticals will continue to grow."	

"But the combination of pressures during the next decade may see a consolidation among health care purchasers and regulators, leading to increased requirements imposed on the industry, such as need clauses; a focus on efficiency; medicine-acquisition practices favouring generic and therapeutic substitution; and price premiums permitted only for therapeutic advantage  . . .  It is more than likely that cost/benefit considerations will become attached to marketing authorization requirements, with the risk of placing massive and costly demands on industry to conduct additional wide-ranging epidemiological studies as a part of preregistration procedures. But much of the way those pressures will operate is still open to influence."				

"There could be a net gain out of all these changes in external circumstances for the European pharmaceutical industry. But it might only be slender. It could even be cancelled out completely if the price of patent term restoration proves to be more controls on research, if opening the internal market leads to unchecked parallel importing, and if tighter health insurance budgets lead to tighter cost control mechanisms . . .   Much will depend on the decisions made in 'political' circles."	

"For instance, how far will European health care budgets squeeze pharmaceuticals? Will the industry be able to demonstrate product value in a way that convinces the critical, sceptical, sophisticated audiences of health care providers and government departments, centralized European control agencies, increasingly influential consumer lobbies and maybe even patients? Will we be able to divert health care purchasers and users from insisting uniquely on short-term value for money? Will the industry successfully persuade national and European authorities that there is more at stake in completing the internal market than merely ensuring free circulation? Or how, in Europe, will the battlegrounds shape up regarding generics (with respect to bioequivalence), confidence concerning the reliability of submissions and of their evaluation, and legitimate strategies to maintain commercial protection for off-patent products?"	

"I believe that the future is still up for grabs. And for that reason, much of the fine-tuning, the way that the marginal changes affect the industry, will depend on how well the industry as a whole plays its own political cards. Insensitive handling will become an expensive mistake. The industry as a whole must make up its mind which card game it wants to be in; political coherence can come only from political cohesion, from a sense of political identity. 	

"Equally, it's no good discussing any of the major trends or key issues as if Europe, the European pharmaceutical market and the players in it were somehow fixed and unchanging. This background is quickly changing and it requires a response from individual companies. Each will find its own form of response - some have gone for mergers. We have already seen some notable examples of supply-side consolidation; I don't need to list the major (and not so major) mergers effected or announced during the last year or so. "	

"Are there any alternatives to the strategy of 'biggest is best'? I believe there are, because no matter how many European directives we see during the next decade, the way medicines are viewed, prescribed and taken will continue to vary from country to country. So there are no universal solutions, even for the largest firms and biggest products."				

"What successful companies in Europe will have to do, whatever their size, is adapt their structures to get the best of both worlds. They must ensure that they are not operating at a disadvantage to newly established firms that are tailored to the new European single market. However, any adaptations must still allow them to continue benefiting from local knowledge."	

"Whichever way firms set about dealing with the new challenges presented by the 21st century, there is no pretending that there will not be some pain. There are financial and human costs in restructuring, with concentrations, lay-offs and compensation payments. There are also costs from tougher competition - will it lead to an increase of unedifying inter-company conflict?"	

"Companies may change products to take maximum advantage of competitive circumstances - more cross-licensing, for instance. Or, more involvement by research-based generics firms - bigger generic demand, tighter regulation of the generic sector and higher generic prices could together amount to an attraction."	

"Whichever way things go in Europe, it is a Catch 22 situation. If operating conditions get worse, the industry will suffer. If they improve, it will attract more players and competition, so the local industry will suffer. The chances of success depend on the extent to which we can ensure that all our companies are successful, not only in generating valuable new products, but also in seeing with a clear eye that their way ahead depends on continually fighting for a better environment in which to operate. And just as you don't discover valuable new drugs without a lot of hard work and commitment, you don't get good results in the operating environment unless you work at it."	

How did you do? Not too hard to identify the year - 1990, just after the EU rules came in to restore patent terms and to impose minimum requirements on the way member states operated their pricing and reimbursement systems, and just before the proposals for the European Agency for the Evaluation of Medicinal Products were finalized.				

Not too hard to identify what was right in the predictions, either - tougher competition, tighter pressure on prices and promotion, clashes concerning intellectual property rights -- in fact, all the same stuff about a better operating environment that the European pharmaceutical industry is still having to say today.	

And as to the 'whom' - it was the then director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Nelly Baudrihaye. Characteristically, she added at the end of her speech: "There are certain privileges attached to age. In my case, one of them is that I can speak authoritatively on this subject, secure in the knowledge that you won't be able to put me on the spot on 1 January 2001 to accuse me of having got it wrong." Right, Nelly.  	

This month, readers are offered the opportunity to take part in a quiz. How many predictions from an old blueprint for the European pharmaceutical industry were correct? Remember, no cheating.

Back to the Future: Does Anything Change, Ever?

The international standard "Quality management systems - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)" is a German initiative that will help the standardization of manufacturing primary packaging materials. A draft of the standard (ISO/CD 15378) has been circulated worldwide for comments by experts.	

The initial work was done by the Deutsches Institut fÃ½mung (DIN) and Normenausschuss Medizin (NAMed), who then submitted the standard to a working group of the International Organization for Standardization (ISO). Draft 15378 is based on ISO/TC 176/SC 2, which is responsible for the development of the ISO 9001 and ISO 9004 international standards as well as other international standards and documents in the ISO 9000 family.	

Draft 15378 provides a major contribution to developing relations between the pharmaceutical industry and manufacturers of primary packaging materials. The packaging manufacturers are certified according to ISO 9000:2000 and the pharmaceutical industry expects its suppliers to meet GMP requirements. This is a great challenge to the manufacturers, who are being increasingly audited and certified in purely GMP-oriented audits by pharmaceutical customers, based on rules applicable to the pharmaceutical industry and individual requirements. However, regarding the "strictness" of requirements to GMP, differences between the pharmaceutical industry and manufacturers of primary packaging materials must be duly taken into account; that is, GMP requirements must be suitably "adapted" to the manufacture of primary packaging materials.	

Draft 15378 provides both the pharmaceutical industry and suppliers with a set of rules enabling them to manufacture products according to defined GMP requirements and to implement quality control and quality assurance measures. An important aim of the draft is for manufacturers of primary packaging materials for medicinal products to obtain an officially recognized GMP certification based on ISO 9001:2000. The draft will create a link between ISO and GMP, ensure that there are common terms and definitions within the pharmaceutical industry and enhance GMP understanding. Additionally, the draft defines the global requirements that packaging manufacturers must meet with regards to the pharmaceutical industry and covers packaging made of glass, rubber, plastic, aluminium, foils and laminates. The new standard is of particular significance because many of these materials are used in the manufacture of parenterals.				

At an ISO meeting last January (2003), a project team was formed to develop industry-specific standardization and information requirements for the various groups of packaging materials. Comments regarding a second draft of 15378 were discussed with international experts of technical committee (TC) 76, and in due course the secretariat of ISO/TC 76 will provide a revised draft. BPI and VFA expressly support this project and request the participation of both the pharmaceutical industry and of the manufacturers of primary packaging materials (

Based on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.

Pharmaceutical Technology Europe-01-01-2004

Staying the Course: The Sixth Annual International Employment Survey

Predicting Flowability and Characterizing Powders

Back to the Future: Does Anything Change, Ever?

ISO Standard for Primary Packaging Materials