Pharmaceutical recordkeeping system
First Claim
Patent Images
1. A method for recordkeeping comprising the steps of:
- (a1) providing a first portable memory with a unique serial number recorded therein, for a first lot of raw material to be received and tested;
(a2) writing raw material identification and test requirements data into the first portable memory relating to the first raw material lot;
(a3) providing a second portable memory with a unique serial number recorded therein, for a sample from the first raw material lot;
(a4) writing said raw material identification, test requirements, and the serial number from the first portable memory into the second portable memory;
(a5) testing the sample and writing test data into the second portable memory; and
(a6) writing the test data and the serial number from the second portable memory into the first portable memory by first reading the identification data from the both the first and second portable memories, comparing the identification data read from the first and second portable memories and writing the test data and the serial number of the second portable memory into the first portable memory if the comparison is favorable; and
(a7) repeating steps (a1) through (a6) using additional first and second memories, for additional lots of raw material.
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Accused Products
Abstract
A recordkeeping method comprises assigning serialized portable memory devices to individual lots of material and manufacturing process batches, writing identification and requirements data into the portable memory devices, writing manufacturing and test data into the portable memory devices during the process and writing the manufacturing and test data from one portable memory device into another by first reading the identification data from the both portable memory devices, comparing the identification data read from the two portable memory devices and writing the manufacturing and test data into the other portable memory device if the comparison is favorable.
64 Citations
22 Claims
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1. A method for recordkeeping comprising the steps of:
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(a1) providing a first portable memory with a unique serial number recorded therein, for a first lot of raw material to be received and tested; (a2) writing raw material identification and test requirements data into the first portable memory relating to the first raw material lot; (a3) providing a second portable memory with a unique serial number recorded therein, for a sample from the first raw material lot; (a4) writing said raw material identification, test requirements, and the serial number from the first portable memory into the second portable memory; (a5) testing the sample and writing test data into the second portable memory; and (a6) writing the test data and the serial number from the second portable memory into the first portable memory by first reading the identification data from the both the first and second portable memories, comparing the identification data read from the first and second portable memories and writing the test data and the serial number of the second portable memory into the first portable memory if the comparison is favorable; and (a7) repeating steps (a1) through (a6) using additional first and second memories, for additional lots of raw material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for recordkeeping, comprising the steps of:
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(a) providing a first portable memory with a unique serial number recorded therein, for a first lot of packaging material to be received and tested; (b) writing packaging material identification and test requirements data into the first portable memory relating to the first packaging material lot; (c) providing a second portable memory with a unique serial number recorded therein, for a sample from the first packaging material lot; (d) writing said packaging material identification, test requirements, and the serial number from the first portable memory into the second portable memory; (e) testing the sample and writing test data into the second portable memory; and (f) writing the test data and the serial number from the second portable memory into the first portable memory by first reading the identification data from both the first and second portable memories, comparing the identification data read from the first and second portable memories and writing the test data and the serial number of the second portable memory into the first portable memory if the comparison is favorable;
(g) repeating steps (a) through (f), using additional first and second memories, for additional lots of packaging material. - View Dependent Claims (12)
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13. A method for recordkeeping comprising the steps of:
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(a) providing a first portable memory with a unique serial number recorded therein, for a first lot of labeling material received and to be tested; (b) writing labeling material identification and test requirements data into the first portable memory relating to the first labeling material lot; (c) providing a second portable memory with a unique serial number recorded in memory, for a sample from the first labeling material lot; (d) writing said labeling material identification, test requirements, and the serial number from the first portable memory into the second portable memory; (e) testing the sample and writing test data into the second portable memory; (f) writing the test data and the serial number from the second portable memory into the first portable memory by first reading the identification data from the both the first and second portable memories, comparing the identification data read from the first and second portable memories and writing the test data and the serial number of the second portable memory into the first portable memory if the comparison is favorable; and (g) repeating steps (a) through (f), using additional first and second memories, for additional lots of labeling material. - View Dependent Claims (14)
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15. A method for recordkeeping comprising the steps of:
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(a) providing a first portable memory with a unique serial number recorded therein, for a first product to be produced from a plurality of lots of raw material; (b) writing product identification, process and test requirements data into the first portable memory relating to the first product to be produced; (c) providing an second portable memory with a unique serial number recorded in the memory, for the first product to be produced from the plurality of lots of raw material; (d) writing product identification and product raw material component requirements data into the second portable memory relating to the first product to be produced; (e) writing the serial number from the first portable memory into the second portable memory by first reading the identification data from both the first and second portable memories, comparing the identification data read from the first and second portable memories and writing the serial number if the comparison is favorable; (f) writing the serial number from the second portable memory into the first portable memory if the identification data comparison is favorable; (g) obtaining a portion of the first lot of material for the first product to be produced and writing material lot data and serial number from a third portable memory into the second portable memory by first reading the material identification data from the third portable memory and the material component requirements data from the second portable memory, comparing the material identification and requirements data read from the third and second portable memories and writing the material lot data and serial number into the second portable memory if the comparison is favorable; (h) writing the product batch data and serial number from the second portable memory into the third portable memory if the comparison is favorable; (i) writing material lot data from the second portable memory into the first portable memory by first reading the product identification data from both the first and second portable memories, comparing the product identification data read from the first and second portable memories and writing the material lot data into the first portable memory if the comparison is favorable; and (j) repeating steps (a) through (i) for each raw material component of the first product to be produced. - View Dependent Claims (16, 17)
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18. The method for recordkeeping comprising the steps of:
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(a) providing a first portable memory with a unique serial number recorded therein, for a portion of the first product to be packaged and labeled; (b) writing packaged product identification, and packaging and labeling process and test requirements data into the first portable memory relating to the packaged portion of the first product; (c) providing a second portable memory with a unique serial number recorded in the memory, for a portion of the first product to be packaged and labeled; (d) writing packaged product identification, and the packaging and labeling material component requirements data into the second portable memory relating to the packaged portion of the first product; (e) writing the serial number from the first portable memory into the second portable memory by first reading the packaged product identification data from both the first and second portable memories, comparing the packaged product identification data read from the first and second portable memories and writing the serial number if the comparison is favorable; (f) writing the serial number from the second portable memory into the first portable memory if the packaged product identification data comparison is favorable; (g) obtaining a portion of the first product to be packaged and labeled, and writing product batch data and serial number from a third portable memory into the second portable memory by first reading the product identification data from the third portable memory and the packaging product requirements data from the second portable memory, comparing the product identification and requirements data read from the third and second portable memories and writing the product batch data and serial number into the second portable memory if the comparison is favorable; (h) writing the packaged product lot data and serial number from the second portable memory into the third portable memory if the comparison is favorable; (i) writing the product batch data from the second portable memory into the first portable memory by first reading the packaged product identification data from both the first and second portable memories, comparing the packaged product identification data read from the first and second portable memories and writing the packaged material lot data into the first portable memory if the comparison is favorable. - View Dependent Claims (19, 20, 21, 22)
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Specification