Loading

Viagra with Fluoxetine

By G. Folleck. Ottawa University.

Psychological techniques for controlling the adverse side effects of cancer chemotherapy: Findings from a decade of research generic viagra with fluoxetine 100 mg with visa. Postoperative chemotherapy and chemohormonal ther- apy in women with node-positive breast cancer buy discount viagra with fluoxetine 100 mg on line. Novel electrical detection of label-free disease marker proteins using piezoresistive self-sensing micro-cantilevers buy 100mg viagra with fluoxetine overnight delivery. Tracking metastatic tumor cell extravasation with quantum dot nanocrystals and fluorescence emission-scanning microscopy. Superparamagnetic nanoparticles for biomed- ical applications: Possibilities and limitations of a new drug delivery system. Polymeric micelles for delivery of poorly soluble drugs: Preparation and anticancer activity in vitro of paclitaxel incorporated into mixed micelles based on poly(ethylene glycol)-lipid conjugate and positively charged lipids. Selective targeting of antibody-conjugated nanoparticles to leukemic cells and primary T-lymphocytes. Nano-encapsulation of azole antifungals: Potential applications to improve oral drug delivery. Synergistic enhancement of selective nanophotothermolysis with gold nanoclusters: Potential cancer therapy. Innovative drug delivery nanosystems improve the anti-tumor activity in vitro and in vivo of anti-estrogens in human breast cancer and multiple myeloma. Liposomal glucocorticoids as tumor- targeted anti-angiogenic nanomedicine in B16 melanoma-bearing mice. Synthesis, characterization and targeting of biodegradable magnetic nanocomposite particles by external magnetic fields. Interaction of functionalized super- paramagnetic iron oxide nanoparticles with brain structures. Lactoferrin and ceruloplasmin derivatized superparamag- netic iron oxide nanoparticles for targeting cell surface receptors. Sub-cellular accumulation of magnetic nanoparti- cles in breast tumors and metastases. Preparation of carbon-coated magnetic iron nanoparticles from composite rods made from coal and iron powders. Plasma synthesis of carbon magnetic nanoparticles and immobilization of doxorubicin for targeted drug delivery. Characterization and anticancer activity of the micelle-forming polymeric anticancer drug Adriamycin-conjugated poly(ethylene glycol)-poly(aspartic acid) block copolymer. Ceramic-based nanoparticles entrapping water-insoluble photosensitizing anticancer drugs: A novel drug-carrier system for pho- todynamic therapy. The embedding of meta-tetra(hydroxyphenyl)chlorin into silica nanoparticle platforms for photodynamic therapy and their singlet oxygen production and pH-dependent optical properties. Influence of particle size on transport of methotrexate across blood brain barrier by polysorbate 80-coated polybutylcyanoacrylate nanoparticles. Encapsulation of 9-nitrocamptothecin, a novel anticancer drug, in biodegradable nanoparticles: Factorial design, characterization and release kinetics. Trastuzumab-modified nanoparticles: Optimisation of preparation and uptake in cancer cells. Poly(ethylene oxide)-modified poly(epsilon-caprolactone) nanoparticles for targeted delivery of tamoxifen in breast cancer. Biodistribution of colloidal gold nanoparticles after intravenous administration: Effect of particle size. Nanomedicine for drug delivery and imaging: A promising avenue for cancer therapy and diagnosis using targeted functional nanopar- ticles. Perumal Department of Pharmaceutical Sciences, South Dakota State University, Brookings, South Dakota, U. Kaushik Department of Biology & Microbiology/Veterinary Science, South Dakota State University, Brookings, South Dakota, U. The biodegradation of proteins into sim- ple amino acids makes them attractive polymers for drug delivery applications. As a result, protein polymers are being increasingly investigated for various nano- enabled drug delivery systems (1). In fact, the first protein-based nanopartic- ulate system is already in the market. In general, nanosystems used in drug delivery range in size from 100 to 1000 nm and are prepared using natural or synthetic polymers or lipids. The drug is encapsulated inside the nanosystem (nanocapsule or nanospheres) or is entrapped in the matrix of the nanosystem (nanoparticles). Alternatively, drugs or other agents of interest are adsorbed, complexed, or conjugated to the surface of the nanosystems. A distinct advantage over syn- thetic polymers is the proven biocompatibility of proteins. Furthermore, they are biodegradable and are broken down into nontoxic by-products. Protein polymers are derived from animals or plants and are, therefore, devoid of monomers or ini- tiators that are found in synthetic polymers. However, the composition and purity of protein biopolymers are difficult to control. Similarly, it is important to protect the protein from premature proteolytic degradation in the body. Although most of the proteins are generally safe, nonautologus proteins can be immunogenic (2). Proteins can be classified into different types based on their source or struc- tural features. This chapter is mainly focused on natural protein polymers derived from animal or plant sources. The properties of different protein polymers used in drug delivery are listed in Table 1. Majority of the published literature on pro- tein nanoparticles is on animal proteins such as gelatin and albumin. On the other hand, there are limited reports on plant protein–based nanoparticles. Animal proteins carry the risk of infection from pathogen contamination with animal tissues. However, animal proteins, such as gelatin, can be easily sterilized due to their thermal stability. In contrast, plant pro- teins are devoid of these issues, and further plant proteins are universally accepted as they can be used even by people who do not consume animal proteins for per- sonal or religious reasons.

The pharmaceutical and Institute areas do not account for much in this phase of the construction and circulation of knowledge proven viagra with fluoxetine 100mg. The “territory” covered by the two networks is permeated more with cell- and molecular-biology knowledge than with biotechnology and bioengineering cheap viagra with fluoxetine 100 mg with amex. The most marked difference remains the signifcant growth in the feld of expertise of molecular oncology- endocrinology for the two Montreal laboratories cheap 100mg viagra with fluoxetine with visa. This cannot be explained entirely by the stronger presence of the hospital sector, since it is strong in all three laboratories. The increased signifcance 301 Catherine Garnier of this feld in the evolution of the network may however be accounted for by the development over the past few years of direct relations between the head of the two Montreal laboratories with pediatric-hospital oncologists who have to cope with the expectations of desperate parents. This hypothesis was corroborated by interviews conducted with some of members of the laboratories. The analysis thus reveals the great diversity of disciplines and collaborations that is necessary at this stage of drug development. All this serves to confrm the contextualization of the construction and circulation of knowledge in terms of differential principles of action. The Object Analyses of Publications As we pointed out earlier, scholarly papers are of major importance for laboratories, and so we frst systematically analyzed the scientifc articles and left the popular articles for later examination. The analysis dealt with the scientifc articles published by the three laboratories about Neovastat, green tea catechin and essential oils, including balsam fr. For Neovastat, the descending hierarchical cluster analysis produced 6 clusters of discourse grouping together 304 elementary context units (e. Looking at the clusters in terms of their segmentation by hierarchical level, we fnd ffth- and sixth-cluster groupings at the frst level. In the frst of these (cluster 5), we fnd terms related to metalloprotease, an enzyme particularly involved in angiogenesis, and a metalloprotease activator. The second (cluster 6) is much broader and is related more to cells, especially the integration of the different mechanisms involving cells and receptors. On the second level, the frst grouping is linked to cluster , which concerns angiogenesis itself; it involves, on the one hand, the concept of how cells propagate, proliferate, migrate, and grow; and on the other, the growth factors closely involved in angiogenesis. On the third level, the clusters from the preceding levels join cluster 2, which has to do with apoptosis, or programmed cell death. On the fourth level, cluster 4 is added; it refers to the plasminolytic system involved in the formation and degradation of blood clots and in several stages of angiogenesis. Finally, at the ffth level, comes cluster 1, which groups together all the basis research procedures such as cell buffers and solutions and the like. The correspondence analysis for Neovastat shows that the frst factor contrasts the discourse on basic procedures, tools, and means with the discourse on the ultimate purpose of the research. At one pole it deals with different types of objects, such as buffers and solutions, and at the other pole it deals mainly with the integration of different mechanisms concerning cells and receptors, programmed cell death (apoptosis), the mechanisms by which tumours are nourished (angiogenesis), factors of cell growth and cell propagation, the system involved in the formation and degradation of blood clots and in several stages of angiogenesis as well as an enzyme particularly involved in angiogenesis (metalloprotease). On the second factor, the classes of discourse concerning experimentation without cells are contrasted with classes of discourse dealing with experimentation with living cells. The frst level of aggregation brings together cluster 1 on the anticancer properties of green tea and cluster 5 on the modes of preparation and distribution within the organism of different types of catechin, the anticancer factor in green tea. At this frst level, we also fnd cluster on the different stages of angiogenesis involving metalloproteases (enzymes that degrade the extracellular matrix allowing a cell to be invaded) along with cluster 3 concerning intracellular signalling by polyphenols such as catechin. Correspondence analysis of the body of articles about green-tea catechin extract indicates that, as in the preceding analysis, the frst factor contrasts discourse focused on procedures with the entire discourse related to the ultimate purpose of the research. It involves, at one pole, material and processes, and, at the other, the different stages of angiogenesis, intracellular signalling by catechin attached to the cell and signalling it to perform such actions as division, extinction and latency; the modes of preparation and distribution in the organism of different types of catechin; and the anticancer properties of green tea. However, while, in the analyses of Neovastat, the second factor contrasts the living with the inert, for catechin it helps us distinguish the effect (bioavailability, absorption) from the understanding of this effect (signalling and modes of action of catechin). On the frst level, cluster 4 concerning bacteria is connected to the general cluster 5, which contains mainly linking words. On the next level, these two clusters are associated with cluster 3, which deals with molecular structure. On the next hierarchical level these clusters join cluster 1, which describes the chemical composition of the substances. On the last level, all these clusters are connected to a two-cluster grouping: cluster 2, dealing with equipment and processes, and cluster 6, which contains the discourse regarding tissue cultures. Correspondence analysis of the third laboratory’s articles brings two factors to light. The frst more technical factor contrasts the discourse on equipment and methods to the discourse on unspecialized knowledge. It contrasts the discourse dealing with living material and the isolation of essential oils to discourse on much more precise chemical compositions. The analyses also confrm that knowledge is broken up in accordance with differential principles of action, revealing categories of knowledge that are well defned and contrasted and that respect the formalism of the presentations for all three laboratories. In addition to more traditional categories of knowledge, such as knowledge on procedures and processes, and basic and clinical knowledge, we fnd two less traditional and contrary categories, the living and the inert. The differential principles of action may also explain the absence of any hierarchization of knowledge; procedural and process 303 Catherine Garnier knowledge is as important as the very specialized knowledge regarding the ultimate purpose of the research. The chronologies The event chronologies were analyzed on the basis of two different sources, the scientifc publications and a press review. In terms of their effect on cancer, the substances are found to be effective, and in terms of sources of information, the majority comes from university research centres. It should, however, be noted that, for Vioxx, the frst published data come mainly from Merck, the company that produced the drug. In the light of these observations and the crisis related the withdrawal of Vioxx from the market, certain questions arise. To what extent does the research carried out before a drug is approved address all the risks suffciently? To what degree does it do so, given that the frst part of the chronology provides little information on the harmful or side effects of the medications? In any event, there are limits to the diversity of the populations involved in clinical trials and to the duration of such trials, so these two dimensions necessarily give rise to some uncertainty. The Vioxx chronology, derived from the abstracts of scientifc studies, does not really allow us, at this stage, to predict crises like those sparked by the withdrawal of the drug. Still, the difference between the chronologies of these substances brings out the fact that plant- and animal-derived extracts are not on the same level as prescription medications. In the case of the plant and animal extracts, almost all that has to be shown is that they are effective in a particular area. In the case of prescription drugs, it is also essential to demonstrate that they are not harmful or, at least, that the contributions they are likely to make outweigh any of their toxic aspects. Information from the abstracts is indicated in the fgure in accordance with its importance in the chronology of the medication: events of moderate importance are shown at a medium distance from the timeline, and events of major importance (withdrawal or approval of the drug, lawsuit or important discovery, etc.

buy 100 mg viagra with fluoxetine with amex

The head of the quality control generally has the following responsibilities; (a) to approve or reject starting materials viagra with fluoxetine 100 mg overnight delivery, packaging materials and intermediate order 100mg viagra with fluoxetine otc, bulk and finished products in relation with their specification; (b) to evaluate batch records; (c) to ensure that all necessary testing is carried out; (d) to approve sampling instructions discount viagra with fluoxetine 100mg otc, specifications, test methods and other quality control procedures; (e) to approve and monitor analyses carried out under contract; (f) to check the maintenance of the department, premises and equipment; (g) to ensure that the appropriate validations, including those of analytical procedures, and calibrations of control equipment are carried out; (h) to ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to need. The authorized person from Quality Assurance is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale. The authorized person will also be involved in other activities, including the following; (a) implementation (and, when needed, establishment) of the 141 quality system; (b) participation in the development of the company’s quality manual; (c) supervision of the regular internal audits or self –inspections; (d) oversight of the quality control department; (e) participation in external audit (vendor audit) (f) Participation in validation programmes. The function of the approval of the release of a finished batch or a product can be delegated to a designated person with appropriate qualifications and experience who will release the product in accordance with an approved procedure 8. The person responsible for approving a batch for release should always ensure that the following requirements have been met: (a) the marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned; (c) the manufacturing and testing processes have been validated, if different; (d) all the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records; (e) 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. Continuing training should also be given, 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. Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, 142 they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. Electrical supply should be appropriate and such that they do not adversely affect, directly or indirectly, either the pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment. Receiving areas should be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage. Washing, cleaning and drying equipment should be chosen and used so as not to be a source of contamination. Materials dispensed for each batch of the final product should be kept together and conspicuously labelled as such. All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity and conformity with the packaging instructions. The purchase of starting materials is an important operation that should involve staff who has a adequate knowledge of the products and suppliers. Finished products should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer. Products returned from the market should be destroyed unless it is certain that their quality is satisfactory; in such cases they may be considered for resale or relabeling, or alternative action taken only after they have been critically assessed by the quality control function in accordance with a written procedure. The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued should all be taken into account in this assessment. Where any doubt arises over the quality of the product, it should not be considered suitable for reissue or reuse. There should be records for the receipt and preparation of reagents and culture media. Reagents made up in the laboratory should be prepared according to written procedures and appropriately labelled. The label should indicate the concentration, standardization factor, shelf-life, the date when re-standardization is due, and the storage conditions. Both positive and negative controls should be applied to verify the suitability of culture media each time they are prepared and used. The size of the inoculums used in positive controls should be appropriate to the sensitivity required. Reference standards prepared by the producer should be tested, released and stored in the same way as official standards. They should be kept under the responsibility of a designated person in a secure area. Secondary or working standards may be established by the application of appropriate tests and checks at regular intervals to ensure standardization. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process. Out-of-specification results obtained during testing of materials or products should be investigated. Records demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated. All tests should follow the instructions and results should be checked by the supervisor before the material or product is released. Sampling equipment should be cleaned and if necessary, sterilized, before and after each use and stored separately. Quality control should evaluate the quality and stability of finished pharmaceutical products and, when necessary, of starting materials and intermediate products. A written programme for ongoing stability determination should be developed and implemented. Stability should be determined prior to marketing and following any significant changes in processes, equipment, packaging materials. X Critical Item/area/system/knowledge is missing or of such Deficiencies nature to warrant serious quality/compliance concerns. All deficiencies under critical category will be marked as “X” and one critical finding will make the manufacturing site unsuitable for acceptance till rectified irrespective of scores in other points. Some users of the checklist find responses to some questions are difficult to quantify on a 0-2 scale and prefer to use a simple “Yes” or “No” approach. In such cases, a “Yes” should be assigned a “1” value and a “No” should be assigned as “0” value. Sanitation - Evidence of widespread accumulation of residues / extraneous matter in the manufacturing areas. Raw Material - Evidence of falsification or misrepresentation of Testing analytical results. Equipment - Premises and equipment not maintained to minimize contamination / generation of particles. Finished - Finished product not tested for compliance with Products applicable specifications before release for sale. Sterile - Sterilization cycles based on probability of survival not Products validated. Deficient (To be marked as “0”) Premises - Physical and electronic quarantine accessible to unauthorized personnel / Physical quarantine area not well marked and / or not followed when used. Maintenan ce of hygienic conditions is excellent and proper documents are available. All the manufactur ing and surroundin g corridors including change rooms are made of epoxy flooring and interior surfaces are free from any cracks or joints. Pls attach equipment lay out, men and material movement, waste movement if applicable. Attach copy of pest / rodent control schedule along with contract agreement if any. No and dispensing areas are well dispensing Dispensin is provided with lighted and booth. Only a g booth clean effectively clean area is ventilated, with air has background.

generic 100 mg viagra with fluoxetine

Drug Director constitutes final agency When providing assistance under para- action discount viagra with fluoxetine 100 mg without prescription, subject to judicial review buy cheap viagra with fluoxetine 100mg. The requirements of this part sonable risk of illness or injury under shall apply to any juice regardless of conditions of use recommended or sug- whether the juice order viagra with fluoxetine 100 mg amex, or any of its ingredi- gested in the labeling, or if no condi- ents, is or has been shipped in inter- tions of use are recommended or sug- state commerce (as defined in section gested in the labeling, under ordinary 201(b) of the Federal Food, Drug, and conditions of use. Raw ag- supplements containing ephedrine ricultural ingredients of juice are not alkaloids are adulterated under section subject to the requirements of this 402(f)(1)(A) of the Federal Food, Drug, part. The definitions of terms in section 201 of the Federal Food, Drug, and Cos- (j)(1) Processing means activities that metic Act, §101. The fol- essing does not include: lowing definitions shall also apply: (i) Harvesting, picking, or trans- (a) Cleaned means washed with water porting raw agricultural ingredients of of adequate sanitary quality. For (m) Shall is used to state mandatory processors of citrus juices using treat- requirements. Department of when stored at room temperature, Agriculture choice or higher quality. I (4–1–10 Edition) food has been processed under sanitary ject to the recordkeeping requirements conditions. A food pesticides, cleaning compounds, sani- hazard that is reasonably likely to tizing agents, condensate, and other occur is one for which a prudent proc- chemical, physical, and biological con- essor would establish controls because taminants; experience, illness data, scientific re- (6) Proper labeling, storage, and use ports, or other information provide a of toxic compounds; basis to conclude that there is a rea- (7) Control of employee health condi- sonable possibility that, in the absence tions that could result in the micro- of those controls, the food hazard will biological contamination of food, food occur in the particular type of product packaging materials, and food contact being processed. This evaluation shall surfaces; and include an assessment of the severity (8) Exclusion of pests from the food of the illness or injury if the food haz- plant. The processor shall (3) Identification of the control meas- monitor the conditions and practices ures that the processor can apply to during processing with sufficient fre- control the food hazards identified as quency to ensure, at a minimum, con- reasonably likely to occur in paragraph formance with those conditions and (a)(2) of this section; practices specified in part 110 of this (4) Review of the current process to chapter that are appropriate both to determine whether modifications are the plant and to the food being proc- necessary; and essed. Each processor shall correct, in (5) Identification of critical control a timely manner, those conditions and points. The records shall (2) Each type of juice processed by contain the actual values and observa- the processor. Whether a have been trained in accordance with processor’s actions are consistent with §120. This re- formed by an individual or individuals view shall occur within 1 week (7 days) who have been trained in accordance of the day that the records are made; with §120. The pur- are any changes in the process that pose of these reviews shall be, at a min- could reasonably affect whether a food imum, to ensure that the records are hazard exists. Such changes may in- complete and that these activities oc- clude changes in the following: Raw curred in accordance with the proc- materials or source of raw materials; essor’s written procedures. These re- product formulation; processing meth- views shall occur within a reasonable ods or systems, including computers time after the records are made; and and their software; packaging; finished (v) The following of procedures in product distribution systems; or the in- §120. The validation of sumer complaints, establishes the need the hazard analysis shall be performed to take a corrective action; and by an individual or individuals who (vi) Additional process verification if have been trained in accordance with required by §120. Each processor and in-process testing, in accordance shall maintain the following records with paragraph (a)(1)(iv)(C) of this sec- documenting the processor’s Hazard tion, are subject to the recordkeeping Analysis and Critical Control Point requirements of §120. I (4–1–10 Edition) (ii) Corrective actions, including all the monitoring occurred, if such actions taken in response to a devi- records can be retrieved and provided ation; and onsite within 24 hours of request for of- (5) Records documenting verification ficial review. All records re- include the time; quired by this part shall be available (3) The signature or initials of the for review and copying at reasonable person performing the operation or cre- times. Processing and other information been previously disclosed to the public, shall be entered on records at the time as defined in §20. The records shall unless they relate to a product or in- contain the actual values and observa- gredient that has been abandoned and tions obtained during monitoring. These the extent that they are otherwise pub- signatures shall signify that these licly available, or that disclosure could records have been accepted by the firm. Job experi- been processed in accordance with the ence may qualify an individual to per- requirements of this part; form these functions if such experience (C) Regularly inspecting the foreign has provided knowledge at least equiv- processor’s facilities to ensure that the alent to that provided through the imported food is being processed in ac- standardized curriculum. The trained cordance with the requirements of this individual need not be an employee of part; the processor. An importer tioning and enforceable in its entirety; may hire a competent third party to or assist with or perform any or all of the (2) Have and implement written pro- verification activities specified in para- cedures for ensuring that the juice that graph (a)(2) of this section, including such importer receives for import into writing the importer’s verification pro- the United States was processed in ac- cedures on the importer’s behalf. The procedures shall provide, at a tain records, in English, that document minimum: the performance and results of the af- (i) Product specifications that are de- firmative steps specified in paragraph signed to ensure that the juice is not (a)(2)(ii) of this section. These records adulterated under section 402 of the shall be subject to the applicable provi- Federal Food, Drug, and Cosmetic Act sions of §120. The or because it may have been processed importer shall provide evidence that under insanitary conditions; and all juice offered for entry into the (ii) Affirmative steps to ensure that United States has been processed under the products being offered for entry conditions that comply with this part. I (4–1–10 Edition) If assurances do not exist that an im- of this section and perform final prod- ported juice has been processed under uct packaging within a single produc- conditions that are equivalent to those tion facility operating under current required of domestic processors under good manufacturing practices. Proc- this part, the product will appear to be essors claiming an exemption under adulterated and will be denied entry. Each juice processor that relies on (a) In order to meet the requirements treatments that do not come into di- of subpart A of this part, processors of rect contact with all parts of the juice juice products shall include in their to achieve the requirements of §120. For duced per day, the sample must be the purposes of this regulation, the taken for each 1,000 gallons produced "pertinent microorganism" is the most but not less than once every 5 working resistant microorganism of public days that the facility is producing that health significance that is likely to juice. The following juice by randomly selecting a package of processors are exempt from this para- juice ready for distribution to con- graph: sumers. This method is designed are applied directly to the juice, except to detect the presence or absence of E. The that the 5-log reduction process begins method is as follows: after culling and cleaning as defined in (1) Sample size. The following definitions toring records for control measures to shall also apply: attain the 5-log reduction standard. I (4–1–10 Edition) numbers assigned by a shellfish control indicate conditions during processing authority to a molluscan shellfish at a critical control point. A processing in- (e) Fishery product means any human cludes any person engaged in the pro- food product in which fish is a charac- duction of foods that are to be used in terizing ingredient. For the purposes Federal, State, or foreign agency, or of this definition, ordinarily the im- sovereign tribal government, legally porter is not the custom house broker, responsible for the administration of a the freight forwarder, the carrier, or program that includes activities such the steamship representative. Every processor (ii) Microbiological contamination; shall conduct, or have conducted for it, (iii) Chemical contamination; a hazard analysis to determine whether (iv) Pesticides; there are food safety hazards that are reasonably likely to occur for each (v) Drug residues; kind of fish and fishery product proc- (vi) Decomposition in scombroid essed by that processor and to identify toxin-forming species or in any other the preventive measures that the proc- species where a food safety hazard has essor can apply to control those haz- been associated with decomposition; ards. Such food safety hazards can be (vii) Parasites, where the processor introduced both within and outside the has knowledge or has reason to know processing plant environment, includ- that the parasite-containing fish or ing food safety hazards that can occur fishery product will be consumed with- before, during, and after harvest. A out a process sufficient to kill the food safety hazard that is reasonably parasites, or where the processor rep- likely to occur is one for which a pru- resents, labels, or intends for the prod- dent processor would establish controls uct to be so consumed; because experience, illness data, sci- (viii) Unapproved use of direct or in- entific reports, or other information direct food or color additives; and provide a basis to conclude that there (ix) Physical hazards; is a reasonable possibility that it will (2) List the critical control points for occur in the particular type of fish or each of the identified food safety haz- fishery product being processed in the ards, including as appropriate: absence of those controls. I (4–1–10 Edition) (ii) Critical control points designed monitored in accordance with §123. Whether a proc- ensure compliance with the critical limits; essor’s actions are consistent with en- (5) Include any corrective action suring the safety of food will be deter- plans that have been developed in ac- mined through an evaluation of the cordance with §123. The records deviation, or shall contain the actual values and ob- (2) Following the procedures in para- servations obtained during monitoring.