- 1-1.) Scope: This procedure covers the issuance and use of Lot, batch and serial numbers for Certificate of Analysis, Batch Records and Product Labels. 2.) Normative References: SOP 4-2-2 Quality Manual SOP 7-5-1-G cgmp Procedures SOP 4-2-4-A Control of Records SOP 4-2-3-C Document and Data Control SOP 4-2-3-D Label Creation and Control SOP 7-5-1-A Product Files SOP 7-5-1-C General Manufacturing Procedure SOP 7-5-3-C & 4-2-3-I Certificates of Analysis 3.) Terms and Definitions: Serial Number: A unique identification number assigned to a container of alcohol as per BATF or industry regulations. Lot Number: A unique identification number assigned to a quantity of raw material or finished product. Lot numbers appear on the Product Files, on the label and on the Certificate of Analysis for that quantity of material, i.e. the Lot. Batch Number: A unique identification number assigned to the batch record. The batch record contains the details for the packaging of that particular batch of material originating from a specific Lot. COA: Certificate of analysis. The actual chemical analysis for that particular lot of chemicals. COA Template: The original or master document for COA s for each chemical. The template lists each specification required in the chemical product monograph, i.e. the product Grade designation. The template also lists the product limits (maximum and minimum requirements) for each specification. The template lists a set of data for these specification (results) from some previous testing review. The COA Template in most cases should (but does not necessarily have to) match the specifications on the product label. Product File: Product documentation verifying origin of manufacturing site, receipt, source, quality review and ultimate disposition for each lot of chemicals
- 2 - moving through our facility. Product files are used for all chemicals. The information in each product file is as listed on FormQA100. Product files are also the vehicles by which the correct labels are produced for finished product manufactured from in-bound raw material. Product files are also the vehicles by which labels are generated for all third party vendors manufacturing product and private labeling for Pharmco. 4.) Application: All raw materials entering the quality system at Pharmco will be assigned a unique Lot Number. All packaging occurrences will initiate a Batch Record with a unique Batch Number. All Pure Ethanol and Specially Denatured Ethanol will be serialized. That means that each label will have a unique Serial Number. 5.) Text: Identification and Traceability (Meets BATF & FDA Requirements) Pharmco Products is a licensed Distilled Spirits Plant (DSP) through the BATF. CFR 27, Parts 1-199, details the regulations that must be complied with. As an industrial DSP, Pharmco is licensed to make any denatured alcohol formulation and sell pure, undenatured alcohol in its various forms. Pharmco is required to account for every drop of Ethanol that flows through our plant. Exact records must be maintained of each lot of Ethanol from production to the actual end user. Package size, quantity, lot, batch and serial numbers are all recorded. This is combined with other sales information such as the customer vita. The BATF requires the use of Lot, batch and serial numbers in order to maintain traceability. These identifying numbers along with other vital information is usually incorporated in the label of the pure alcohol or denatured ethanol product and/or is always documented on the Bill of Lading which accompanies the shipment of product. In tandem with our computer system and quality records, any lot of Ethanol can be traced to all those who received it, in pure or denatured forms. Likewise any finished product can be traced back to the original lot.
- 3 - Pharmco is capable of researching to the day of filling and the operator doing the work. Pharmco maintains procedures for identifying products from receipt, through production and delivery. All incoming raw materials are accompanied by supplier identification. Upon receipt, all raw materials are evaluated. Approved chemical raw materials are assigned an identification number (lot number for bulk and nonbulk materials, and denatured raw material number for denaturants used exclusively as denaturants). Product files are generated for all materials and for all materials and products requiring a quality plan. Rejected raw materials are identified, segregated and quarantined until they can be returned to the supplier. Batch records are maintained for all production runs at the Brookfield facility. The identity numbers of all ingredients used for the run are recorded on the batch record. All batch records are reviewed and signed off by the lab on a daily basis. The laboratory staff documents rework and/or approval on the batch record. Batch records also contain the manufacture date and customer information. In this case the customer may be a single customer, several customers, or stock. Each finished product bottle or container is clearly labeled. The bottle and container label for Ethanol identifies the following: -Pharmco as the manufacturer (DSP CT-18) -Product name/grade -Hazardous rating -Lot Number -Catalog Numbers applicable to this product -NFPA Rating (Health, Flammability, Reactivity) -DOT Shipping Information Each case of product is also labeled with additional information In accordance with BATF regulations, a serial number is assigned to each container of alcohol. The lot number and serial number are recorded on each bill of lading.
- 4 - Serial Number: A unique identification number assigned to a container of alcohol as per BATF or industry regulations. Serial numbers for cases of pure ethyl alcohol and denatured alcohol are controlled by regulations set forth in Part 19.594 of CFR 27. Cases are serialized beginning with 000001 and running consecutively up to 100,000. When the numbering in any series reaches 100,000, the series will be recommenced. A log of these serial numbers is maintained. Serial numbers for pails and drums are controlled by Part 19.593 of CFR 27. Serial numbers used at Pharmco are comprised of two parts. The first component is a five part entry. The first two digits are the year in which the product was filled. The third entry is a letter that reflects the month in which the product was filled. The letters signify the following months: A - January; B- February; C - March; D - April; E - May; F - June; G - July; H - August; I - September; J - October; K - November; L - December. The final two digits signify the date on which the product was filled. The second component of the serial number is the number of the drum filled within a series. For example, a drum of 190 proof was filled on March 28, 1996. It was the 25th drum of 190 proof to be filled on that day. Drums of 190 proof were the second item filled on March 28, 1996. The serial number of the 25th drum of 190 proof would be 96C28B-25. Records of serial numbers are maintained. LOT Number: All finished products will be given a lot number. For Ethanol products the lot number defines the bulk of the chemical(s) in the finished good, additional information on denaturants and product packaging can be obtained from the batch record. Lot numbers for inbound raw material are handled differently based on the volume of product. All bulk solvents are assigned a lot number. LTL shipments of non-bulk chemicals can be re-assigned a Pharmco Lot number or the Vendor Lot number (if clearly marked on the package) can be used. Use of the vendor lot number must be clearly documented in the product file. The batch number associates the finished good to a batch record. All Reagent and Specialty Chemical finished product will receive a lot number, but not necessarily a batch number. Lot Numbers - Bulk (larger than totes) Material Bulk materials are assigned a seven-digit lot number as follows:
- 5 - The first two digits denote the year in which the product was received. For example, all alcohol shipments received in 1994 have a lot number that starts with 94. The third and fourth digits denote the month during which the product was received. For example, all product received in November of 1994 have a lot number that starts with 9411. The fifth and sixth digits denote the day on which the product was received. For example, all product received on November 28, 1994 will have lot numbers that start with 941128. The seventh digit denotes the tank in which the product is stored. For example, 190 proof ethanol received on November 28, 1994 is stored in tank 1. The lot number for this product is 9411281. If bulk product is not unloaded into a tank (i.e. It is directly packaged) the seventh digit will be assigned by VP Operations. The tank storage list (Form Q316) which lists the lot number of a particular tank on a given day, is updated and distributed electronically on a daily basis by quality control department. The production staff maintains a posting of the tank list in the production area. These tanks are not drained between shipments. When a new shipment is received, all of the product in the tank is given a new lot number. Lot Numbers for Denatured Alcohol There are two components of a lot number for denatured alcohol. The first component is the seven-digit lot number assigned to the pure alcohol used in the manufacture of the denatured alcohol. The second component is the formula number of the denatured alcohol. The first and second components are separated by a hyphen. For example, Specially Denatured Alcohol 3A made with 190 Proof Ethanol Lot 9411281 is given the lot number 9411281-SD3A. Lot numbers for all other components are recorded on the bath record. Lot Numbers for Cut Alcohol There are two components of the lot number assigned to cut alcohol. The first component consists of the seven-digit lot number assigned to the pure alcohol used to manufacture the cut alcohol. The second component is the name of the cut product. The first and second components are separated by a hyphen. For example, 140 proof ethanol manufactured with 190 proof ethanol lot 9411281 would have the lot number 9411281-140 Proof. Lot Numbers for 192 Proof Ethanol Ethanol 192 is given a lot number based on its production status. For example, if 192 ethanol is made from 200 proof ethanol added to 190 on a drum by drum basis, the product is given the lot number of the 190 proof ethanol. The lot
- 6 - number of the 200 proof is recorded as part of the batch record. If ethanol 192 is blended in a tank, it is given an appropriate lot number based on the day and tank number. Lot Numbers for Reagents/Specialty Chemicals Reagents and Specialty chemicals will routinely maintain the supplier s lot number or use the purchase order number as the initial 6 digits. In certain circumstances, the QA/DC department or the VP of Operations may use an alternate lot number for the finished product goods. However, the finished product lot number will be traceable to the raw material lot number via the product file. That system uses the purchase order as the main number for a lot number. For instance, PO 300726 for xylene and toluene may generate Lot 300726-XYL and 300726-TOL, respectively. Lot Numbers for Blind Shipments Any blind shipment maintains the lot number assigned by the vice-president of operations. The lot numbers of blind shipments are handled on a case by case basis. BATCH NUMBERS The batch number is assigned on the batch record (Form P001) for each production run (filling operations, pack down operations, and re-label operations, see SOP 7-5-1-C General Manufacturing Procedure). The first two digits of the batch number are the last two digits of the year, e.g. in year 2000 the batch number begins with 00. The next one to three digits is the chronological day of the year, e.g. February 25 is the 56 th day of the year, so February 25, 2000 will have batch number 00056. The batch number is then followed by a dash (-) and then each individual batch record is consecutively numbered with a two digit number starting with 01, then 02, -03, etc. So the first batch record on February 25, 2000 is 00056-01; the twenty-third batch record on this day would be 00056-23. QC NUMBER COA s may also contain a QC Number. The QC number is a second reference number to aid in identifying the source or particular production batch of a product. This may be different than the lot number that appears on the product label and the COA for several reasons. Two examples: Labels may have been preprinted, so that the lot number was designated, but then the material available changed before product was made (new lot of material received). Denatured alcohol products receive a lot number based on the lot number of the pure ethanol used
- 7 - (5.2.2 above), so that several different batches of the same product may be made from a single pure ethanol lot, and will therefore have the same lot number. If assigned, the QC number may take more than one form. For most products, the qc number will be the actual lot number of the material that was used for that product. The batch number may be used for the QC number to separate different production batches of the same lot number, as in the case of denatured ethanol products (see reference below). The QC number may also be a reference number designated by the QC staff, and documented in the product file. Regarding our lot numbering system. Pharmco is required to follow the BATF regulations in this regard which is opposite of the FDA (cgmp) vocabulary. Under the BATF the "batch" is preceded by the "lot", i.e. the rail car is the lot and the fill is the batch. cgmp vocabulary is opposite of this. This however can lead to two separate tank wagons of Reagent Alcohol (or any denatured alcohol) having the same lot number but different analysis. In spite of the fact that our CofA's do contain the date of manufacture and the customers PO# and comes attached to the Bill of Lading, this may be insufficient for FDA guidelines. Therefore, Pharmco will begin to record the batch number on our certificates where the verbiage "QC#" appears. This will immediately tie in that "batch" to our batch records etc. Regarding our lot numbering system at Kinder Morgan Philadelphia Terminal and Certificates of Analysis filled out by Laboratory Services Inc. Lot #s: Shore Tanks The lot #s for the shore tanks are to be based on the date they are approved, and shore tank #. For example: Shore tank #226 is/was approved on 05/09/05. The Lot # would be: 050509226KMT Where the first two digits are the year, the third and fourth digits are the month of the year, the fifth and sixth digits are the day of the month that the tanks are approved on, the seventh - ninth digits are the shore tank number, and the last three digits are always going to be KMT (Kinder Morgan Terminal). This lot number is to remain in effect until the next time the tank has new material added to it. Out Bound Products The Lot numbers of out bound products will be based on the lot number of the shore tank that the ethanol it is being pulled from, and an abbreviation for the final product. For example: A shipment of SDA 39C 190
- 8 - is pulled from shore tank # 226 that has the lot # 050509226KMT. The Lot number of the finished product would be: 050509226KMT-SD39C-190 Where the first twelve digits are the lot # of the shore tank the ethanol is pulled from, a hyphen (-), Blend abbreviation, another hyphen (-), and the proof the finished product. QC #s: The QC Number is a tracking number that all paperwork about a sample can be pulled up by. Since every sample at Lab Services has an LWO # that all the data is saved under, The Lab Services Work Order will be used as Pharmco s QC #. Date: in the format of XX/XX/XX PO #: can be found on the order form sent by Pharmco that goes to LSI, KMT, & DANA Analyst/Date: Analyst initials, followed by the date in format XX/XX/XX Compartmented Trucks: For compartmented Trucks, each compartment is to receive a separate COA. On the COA, after PO #, a line is to be added indicating the compartment number. Example: Compartment # 3 6.) Revision History: This document was revised on 06/27/05 by PJM in accordance with Q9001:2000 requirements. This printed document was printed on: 3/12/2007. This printed document is valid for 5 days after the print date. All obsolete documents must be appropriately marked or discarded.