| || |
Special Internet Prices.
Fast & Guaranteed Worldwide Delivery!
Secure & FAST Online Ordering.
Our Drugstore Is The Most Trusted Online Drug Supplier.
Related post: importation is not sufficient to assure the quality of those drugs. Two foreign
drug manufacturers indicated that CGMP regulations had a significant impact on
their operations. Another foreign manufacturer said their facilities were
inspected annually by FDA with respect to antibiotic certification and new drug
The act applies to drugs introduced into interstate commerce in the United
States, including drugs imported from other countries. It does not, of course,
apply to manufacturing of drugs in other nations if the drugs are not brought
into the United States. Many foreign countries, however, have adopted
requirements similar to CGMP regulations, and foreign manufacturers may be
subjected to inspection by their own governments. International organizations
such as the World Health Organization and the European Free Trade Association
provide manufacturing standards and reciprocal agreements between participating
countries. Overseas pharmaceutical manufacturers who export to the United
States are inspected by FDA or under reciprocal inspection agreements as part of
the new drug application approval process and antibiotic drug certification, and
individual drug products are subject to intensive examination, including
testing, before being allowed into the United States. If, for example, there is
a question regarding the safety, identity, strength, quality, or purity of a
drug product offered for import, FDA has authority to deny entry of the article
unless factory inspection is permitted or inspectional information is available
about those firms covered under reciprocal inspection agreements. The United
State currently has reciprocal inspection agreements under which governments
will exchange inspection information about domestic firms in lieu of conducting
overseas inspections. These agreements are with Sweden, Switzerland, and
Canada. Therefore, the Commissioner finds that there is adequate coverage of
imported drugs to assure compliance with CGMP regulations.
45. Several comments referred to provisions in the Medical Device
Amendments of 1976 and requested that FDA consider providing for exemptions from
or variances to the CGMP regulations and special advisory assistance as Congress
specifically mandated regarding FDA regulation of small manufacturers of medical
devices. Along the same lines, a substantial number of comments were received
from "small" drug manufacturers or organizations representing "small" drug
manufacturers who strenuously oppose most of the proposed changes in the CGMP
regulations. The tenor of the majority of the comments was that the proposed
changes would seriously affect the initial and continuing costs of a "small"
drug manufacturer but probably have little economic impact on, or could more
easily be absorbed by, a "large" pharmaceutical manufacturer. Several comments
expressed concern that generic drug manufacturers might be eliminated because
they could not meet all the requirements of the proposed CGMP regulations and
still compete in the marketplace. Arguments were presented that, because small
manufacturers very often are involved with the manufacture of a small number of
products (frequently less potent over-the-counter preparations) and almost by
definition have small physical facilities, limited equipment, and few personnel,
extensive formal quality control procedures are unnecessary to assure high
quality of the drugs manufactured. One comment, apparently from a small
manufacturer, agreed in principal with the proposed CGMP regulations, felt that
size had very little to do with achieving good manufacturing practice, and
offered comments on specific sections of the proposed CGMP regulations.
The Commissioner rejects the contention that quality control procedures are
unnecessary in the case of small firms; FDA's experience is that quality control
procedures falling below those described in these regulations, in firms of great
or small size, are often responsible for lack of drug product quality. The
Commissioner also rejects the argument that less control need be exerted over
so-called "less potent over-the-counter preparations," which respondents stated
are often manufactured by small firms, for the reasons explained in paragraph
42(h) Buy Furazolidone above.
The Commissioner believes that the final regulations will be no more
burdensome for small manufacturers than for others. Many interpretations
offered in comments on specific sections strongly suggested that the intent of
the proposed regulations had been misunderstood. The language has been
clarified in the final regulations. In other instances the requirements were
reworded to provide for more flexibility for the varieties of procedures and
controls that may be utilized by various manufacturers.
The Commissioner does not believe a specific provision within the CGMP
regulations for variances to these regulations is necessary for small
manufacturers. A mechanism already exists, however, in 21 CFR 10.30 for firms
to petition for variances to or amendments in any regulation when the
requirements are not reasonably attainable.
For many years FDA has conducted and participated in numerous seminars and
workshops designed to assist drug firms in interpreting and carrying out the
requirements of CGMP regulations. Additionally, the agency has made films and
publications available that are also designed to assist drug firms in their
efforts to comply. The agency is committed to continuing these voluntary
compliance efforts especially designed to assist small businesses.
46. Several comments noted that the current good manufacturing practice
regulations do not pertain to veterinary biological products. One respondent
suggested that the section specifically state that these regulations apply only
to human biological products.
The Commissioner believes that the section as proposed clearly establishes
applicability to pertinent biological drug regulations, but for consistency with
references elsewhere in the CGMP regulations to human biological drug products,
he is revising 210.2 to specifically include reference to biological drug
products for human use.
47. Several comments requested clarification of the last sentence of 210.2
to show that conflicting or contradictory regulations would be superseded by the
one specifically applicable to the drug product.
The Commissioner finds that the proposed wording clearly states his intent.
Certainly, in the case of conflicting or contradictory regulations, it will be
impossible to Furazolidone Tablets comply with all regulations and the regulation that is
specifically applicable to the drug product in question would apply.
48. A comment suggested that if medicated premixes are meant to be
excluded from Part 210, then Part 226 should be specifically excluded.
The meaning of this comment, as it relates to 210.2 is not clear. The
Commissioner advises that Part 210 applies to all the regulations in Parts 211
49. One person proposed that the term "drug product" be replaced with the
words "commercial dosage form" to exempt drugs undergoing development from the
requirements of these regulations.
The Commissioner finds that, as stated in 211.1, these CGMP regulations
apply to the preparation of any drug product for administration to humans or
animals, including those still in investigational stages. It is appropriate
that the process by which a drug product is manufactured in the development
phase be well documented and controlled in order to assure the reproducibility
of the product for further testing and for ultimate commercial production. The
Commissioner is considering proposing additional CGMP regulations specifically
designed to cover drugs in research stages.
The Commissioner received hundreds of comments regarding definitions.
General comments are listed immediately below; comments regarding specific
definitions follow in numerical order.
50. One respondent said this section is inconsistent because certain terms
such as "drug" and "establishment" which are defined in the act are not defined
here, while other terms which are defined elsewhere are also defined here.
The Commissioner believes that the length of part 210 would be
unnecessarily increased by including in this part the definitions of terms that
are well known or already defined in the act. Other terms the meaning of which
Related links: Buying Zyban, buy flomax, buy lamotrigine generic, generic ibuprofen online, where to buy motilium without prescription, purchase minoxidil 5, my synthroid 112mcg free t4 1.48, diflucan buy, buying clomid online uk, where to buy bactrim trimetoprima y
| || |