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Of the universe. We are responsible to nothing outside ourselves; for we are the kingdom, the power, and the glory forever and ever."-- * Jeremy Rifkin, Algeny 1983 ; , p. 244. * Rifkin tells us that "evolution somehow magically creates greater overall value and order." In blatant violation of the Second Law of Thermodynamics, * Rifkin sees all disorder producing more perfect order. "We believe that evolution somehow magically creates greater overall value and order on earth. Now that the environment we live in is becoming so dissipated and disordered that it is apparent to the naked eye, we are beginning for the first time to have second thoughts about our views on evolution, progress, and the creation of things of material value Evolution means the creation of larger and larger islands of order at the expense of ever greater seas of disorder in the world. There is not a single biologist or physicist who can deny this central truth. Yet, who is willing to stand up in a classroom or before a public forum and admit it?"-- * Jeremy Rifkin, Entropy: A New World View 1980 ; , p. 55. Evolution has became a scientific religion which men come and bow before and yield their reasoning powers. "In fact [subsequent to the publication of Darwin's book, Origin of Species], evolution became in a sense a scientific religion; almost all scientists have accepted it and many are prepared to `bend' their observations to fit with it mind, the theory does not stand up at all If living matter is not, then, caused by the interplay of atoms, natural forces, and radiation, how has it come into being? I think, however, that we must go further than this and admit that the only acceptable explanation is creation. I know that this is anathema to physicists, as indeed it is to me; but we must not reject a theory that we do not like if the experimental evidence supports it."-- * H.S. Lipson, "A Physicist Looks at Evolution, " Physics Bulletin, Vol. 31, p. 138 1980 ; [emphasis his]. We do not know how it could have happened, we have no evidence, and appealing to it as our religion is no solution. "We still do not know the mechanics of evolution in.

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Since 1950, there have been an increased number of reports of hypersensitivity to sesame from the United States as well as other countries Israel, Australia, and Western Europe ; . Sesame allergies affect all ages, including infants. The symptoms, which include wheezing, urticaria, and angiodema can be life threatening. Sesame allergy is certainly not uncommon. In Australia it is the fourth most common allergen and it ranks second in Israel. The consumption of sesame is soaring. Burgers served in buns topped with sesame seeds are probably the most familiar source in this area. Tahini and hummus are growing in popularity with all ages. In spite of the growing use of sesame seed and sesame oil in the pharmaceutical and cosmetic industries, research and public awareness of sesame allergy are very limited. There is widespread concern among many authors that the common use of sesame in food may eventually cause sesame to be a major food allergy similar to peanut and topiramate.

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Dichloralphene * divalproex sodium, ext. rel. DEPAKOTE ER $$$ butorphanol * STADOL CIV ; L ; $$$$ L ; limit 3 bottles month-nasal spray only ergotamine tartrate caffeine CAFERGOT $$$$ dihydroergotamine mesylate D.H.E. 45 $$$$$ dihydroergotamine nasal MIGRANAL $$$$$$ zolmitriptan ZOMIG L ; $$$$$$ L ; limit 12 tabs month sumatriptan IMITREX L ; $$$$$$ L ; limit 9 tabs, 2 syringes month, 6 nasal spray devices month ANTIANXIETY AGENTS Benzodiazepines alprazolam * not XR ; XANAX CIV ; $ diazepam * VALIUM CIV ; $ oxazepam * caps only ; SERAX CIV ; $ lorazepam * ATIVAN CIV ; $$ Miscellaneous buspirone * BUSPAR $$$$ ANTICONVULSANT MEDICATIONS Barbiturates phenobarbital * CIV ; $ Benzodiazepines clonazepam * not wafers ; KLONOPIN CIV ; $$$ diazepam DIASTAT CIV ; L ; $$$$ L ; Limit 2 boxes per month Hydantoins phenytoin * DILANTIN $ Succinimides ethosuximide * ZARONTIN $$$ Adjuvant Anticonvulsants primidone * MYSOLINE $$ divalproex sodium ext. rel. DEPAKOTE $$$ gabapentin * NEURONTIN $$$ valproic acid * DEPAKENE $$$ lamotrigine LAMICTAL $$$$ topiramate TOPAMAX $$$$ levetiracetam KEPPRA $$$$ Sulfonamides zonisamide * ZONEGRAN $$ Miscellaneous carbamazepine * TEGRETOL $ carbamazepine TEGRETOL XR $$ oxcarbazepine TRILEPTAL $$$ ANTIDEPRESSANTS Tricyclic Antidepressants amitriptyline * ELAVIL $ imipramine * tabs only ; TOFRANIL $ nortriptyline * PAMELOR $ desipramine * NORPRAMIN $$ protriptyline VIVACTIL $$ amoxapine * $$$ clomipramine * ANAFRANIL $$$ doxepin * SINEQUAN $$$ MAO Inhibitors phenelzine NARDIL $$ tranylcypromine PARNATE.

Details in respect of purchase of products for resale Class of Goods 1 ; Ointments 2 ; Liquids 3 ; Capsules 4 ; Tablets 5 ; Ampoules vials 6 ; Powders 7 ; Other Raw & Packing Materials Units Kgs Ltrs Nos Nos Nos Kgs. Kgs Quantity in 000's ; 100.39 93.48 ; 122.03 124.53 ; 9010.39 12867.13 ; 105836.59 85956.32 ; 11014.40 11190.11 ; 3.98 0.00 ; Value Rs in lakhs ; 553.24 694.99 ; 330.96 377.24 ; 143.73 199.10 ; 1144.99 993.12 ; 157.47 100.08 ; 29.54 0.00 ; 516.33 43.06 ; 2876.26 2407.59 and valaciclovir.

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Contamination and mix-ups. The quality assurance system met in general the requirements of WHO GMP. 2. General Approach to Good Manufacturing Practices The manufacturing site consisted of several buildings dedicated to specific production and control activities. The infrastructure and general approach to Good Manufacturing Practices was acceptable. 3. Qualification and Validation A system for qualification and validation was in place and master documentation on qualification and validation existed. The formats of validation and qualification protocols and reports in some cases lacked details. The documentation on the qualification of some of the areas rooms ; , equipment and processes were incomplete. 4. Documentation System The company had an extensive and well structured documentation system. Besides a few exceptions, the procedures were described in writing and associated records were available. A few SOPs did not give sufficient detail on the respective procedures, and some SOPs were not followed. Records were not always completed by the operators and some changes in entries were observed. Some deviations were not appropriately managed and documented. 5. Premises The construction was relatively new. In general, the construction, and maintenance of the premises were acceptable. There were some constraints in terms of design and flow of material and personnel. 6. Equipment The manufacturing and laboratory equipment were generally suited for their intended purpose. Some were not qualified properly OQ, PQ ; and consistency in performance had therefore not be proven. 7. Materials Materials were generally handled in an acceptable manner. Some materials were not labeled properly to indicate their status. 8. Sanitation and Hygiene The level of sanitation and hygiene was acceptable in general. 9. Complaints and Recalls The system of complaint handling and recalls were not inspected in detail during this inspection as it was reviewed in a previous inspection. 10. Contract Production and Analysis Not applicable for this inspection, for instance, drug effects more side topamax.
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