| Nutritional Manufacturing
Profile Of Advanced Diets UK & USA
BUILDING AND FACILITIES
The
manufacturing area is designed to facilitate the operation from the time of receipt of raw
materials to the time of shipping of the finished product. The areas are organized in a
manner to prevent mix-ups and contamination of raw materials, packaging components and the
products manufactured. The areas allocated to different operations are as follows:
1. Receiving and quarantine area
2. Warehouse for storage of raw materials and other components
3. Pharmacy and blending
4. Staging area for storage of in-process materials
5. Production area for encapsulation
6. Production area for tableting
7. Coating area
8. Packaging and labeling area
9. Area for storage of finished products
10.
Quality control laboratory
Adequate
lighting and ventilation is provided through the building and sanitation procedures are in
place to ensure the building is maintained clean and free of rodents and other vermin. All
manufacturing areas, including storage of finished products, are air conditioned.
Individual dust collection units service the areas of pharmacy and blending, tableting,
encapsulation and coating, in order to prevent build up of dust and microorganisms, and
product contamination. Separate rooms and/or cubicles are employed for the performance of
specific operations which are equipped with appropriate equipment and separate air
handling system using negative air pressure for prevention of cross-contamination.
PRODUCTION
AND PROCESS CONTROLS
  
Written
procedures are strictly followed in production of nutritional products to ensure their
identity, strength, quality and purity. In process controls have been established to
assure that the product is made reproducibly and according to set specifications. Process
control functions are documented at the time of performance and processing records are
maintained throughout the manufacturing process.
Equipment
used in the manufacture of a product are properly maintained and thoroughly cleaned
according to written procedures to prevent malfunction and contamination of the product.
Procedures are in-place for cleaning, set-up and operation of equipment as well as its
inspection prior to use. A log of use, cleaning and maintenance is kept for each
processing equipment.
To
ensure batch uniformity and integrity of the product, procedures have been established for
in-process testing. These control procedures include, where appropriate:
1. Appearance
2. Weight variation
3. Tablet thickness
4. Tablet hardness
5. Friability
6. Disintegration time
7. Dissolution time
In-process
specifications are consistent with finished product specifications. The quality control
unit may reject a product at any stage of the manufacturing process, if the purity or
quality of the product is compromised. Rejected products are quarantined until an
investigation of the problem is completed.
EQUIPMENT
AND CAPACITIES
  
Equipment and
Capacities are reviewed on an ongoing basis for upgrading due to more efficient available
machinery and productivity needs. Two 8 hour
shifts are normally run with and third shift available for peak times.
1. Granulation
Dry Granulation: Chilsonatar (capacity
of 1000 kilograms per Day)
Wet Granulation: Standard Oven
(capacity of 500 kilogram per Day)
Fluid Bed Dryer
(capacity of 160 kilograms per Hour)
2. Blending
2- 50 cubic feet Patterson Kelley V-Blenders
1- 75 cubic feet Patterson Kelley V-Blenders
3. Tablet Compression
5- BB-2 Type High Speed Compression
7- D-Tooling Compression
capacity of approximately 150 million per month
4. Encapsulation
4- Fully Automatic Encapsulators
6- Semi Automatic Encapsulators
capacity of approximately 45 million capsules per month
5. Powder
Powder Filling Machine
6. Coating
4- Conventional 48” Coating Pans
2- Excella Coaters (for Film Coating and Enteric Coating)
7. Packaging
2- Fully Automatic Lines (including all standard bottle packaging services, such as
filling, cottoning, capping, induction sealing, neck sealing, full body sealing, labeling)
2- King TB-4 Tablet Counters
Specialty Services:
Full Body Sealing
Square Bottle Filling
Induction Sealing
8. Quality Control
Tablet/Capsule Inspection Lines allow for a visual approval of all products. These lines are also equipped with metal
detection. New production is compared to
earlier standard samples to ensure the ongoing consistancy of products.
A fully equipped QC Laboratory allows for a complete complement of tests ensuring
that potencies fully match label requirements, proper disintegration occurs, tablet
hardness is correct and all other aspects of the product meet specifications and
standards. Our QC Laboratory is equipped for
USP and NF testing including the following:
High Pressure Liquid Chromatography
Spectrophotometer
Thin Layer Chromatography
Atomic Absorption
Friability
Disintegration
Dissolution
Hardness
Full Microbiologic
RECORDS
AND REPORTS
All
production and analytical records associated with a batch of a product are retained for at
least one year past the expiration date of the batch. Records are also maintained for all
raw materials and other components for at least one year after the expiration date of the
last lot of product incorporating any of these materials or components.
1. Raw Materials: Raw materials and packaging
components are purchased from reputable suppliers. A Certificate of Analysis is obtained
from the supplier which is maintained by the Quality Assurance Group for at least one year
past the expiration date of the product. All raw materials received are identified and
checked for their physical characteristics, and identified according to the supplier label
claim and the purchasing department. An inventory record is generated for each lot of
material which is used by the pharmacy to maintain a log of material use. Samples are
withdrawn and submitted to QC for testing according to specifications and Standard
Operating Procedures (SOP's) set forth.
2. Packaging Components and Labels: Containers,
closures, cotton, seals and polyethylene bags are obtained from reputable suppliers and
physically checked upon arrival for quality and specifications, using statistical
sampling. Customer's labels are checked against the master label kept in locked cabinets,
and are issued in the product labeling operation under strict controls. Inventory records
for packaging components and labels are maintained by the packaging group.
3. Master Formula:
A master formula, along with a product number, is issued for each product.
The formula contains the name and strength of the product, product specifications,
ingredients and the quantities to be used, as well as manufacturing instructions. The
master production records also provide for recording the lot number of each material used,
weight checks, the date(s) of manufacturing and production yield.
4. Lot Number and Batch Size: Upon receipt of an
order , the product to be manufactured is entered in the master production book and a lot
number is assigned according to standard operating procedures. The lot number consists of
seven digits. The first three digits identify the month and year (i.e. 005 for May 2000),
followed by three digits for sequential identification of receipt of orders. The seventh
digit is usually a one and is reserved for designation of sublots (i.e. 1, 2, 3, etc.)
within the same batch order. A complete lot number for example would be 055-0120. The size
of each batch is determined by the production personnel according to the size of equipment
to be used. Each lot, or sublot thereof, is manufactured and tested under essentially the
same conditions. Representative retained samples and the manufacturing records are
maintained for a minimum of one year past the expiration date of the product.
5. Issuing of Batches: Upon receipt of an order, a
lot number is assigned and batch folders are issued by the planning group. The batch
folders include the formula, manufacturing instructions and all in-process control records
to be used during manufacturing. Upon scheduling, the batch records are forwarded to the
Director of Operations who releases them to the Pharmacy. All manufacturing records are
filed according to product number and lot number, and maintained by the Director of
Operations.
MANUFACTURING
PROCEDURES AND CONTROLS
 
 
 
1. Pharmacy: Balances are calibrated on a daily basis
and all utensils are kept clean. One ingredient is brought into the pharmacy at a time. To
avoid any errors or mix-ups, all containers are labeled and placed in designated areas in
the warehouse. Before withdrawal of the raw material, the containers are checked by the
operator for correctness of label and receiving number. Work is initiated one batch at a
time in the pharmacy following standard operating procedures of weighing and checking each
raw material. Weighed batches are labeled and placed on pallets for further processing. A
log book is maintained for all batches prepared by Pharmacy. Each material weighed out is
subtracted from the raw material inventory record. Once a particular lot of raw material
is exhausted the inventory card is forwarded to the Director of Operations for filing.
2 Mixing and Granulation: Equipment used for
blending, granulation and milling are checked for cleanliness by the supervisor before
use. Batches are processed following written
manufacturing instructions. Upon completion,
powder blends are stored in fiber or plastic drums lined with polyethylene bags, sealed,
labeled, reconciled, and transferred to the staging area for either compression or
encapsulation. If a product is to be reworked because of processing problems, the product
is quarantined, appropriate adjustments are made to the formula and records are forwarded
to the pharmacy. A log book is maintained for all batches processed by the blending group.
3.
Compression/Encapsulation: The production supervisor checks the equipment for cleanliness,
identifies the product to be processed and then transfers the powder blend to the
designated equipment. Samples of the product are checked against a retained sample to
match color and other specifications as per master formula. A sample is also sent to
Quality Control for disintegration testing. If the sample meets specifications, the
product is entered in the machine log book and production commences. In-process records
are prepared and the capsule or tablet weight, tablet thickness and tablet hardness are
recorded, as appropriate, every half-hour. Tablets are collected in polyethylene lined
boxes, labeled and kept in the room until the batch is completed. Upon completion of
tableting, the product is reconciled and transferred to coating or to the packaging
quarantine area. Capsules are collected in polyethylene lined drums and upon completion
the batch is reconciled Subsequently the capsules are deducted and sent to packaging. If a
product does not meet specifications, it may be reworked as per set procedures, and batch
records are updated to indicate all adjustments made to the formula and product
specifications.
4.
Coating: Tablets are coated soon after completion of the batch and tablets are collected
in polyethylene lined boxes. Each batch is reconciled and entered in the coating log book
and then forwarded to packaging for either bottling or bulk packaging. Products that are
sent outside for coating are entered in a separate log book for outside services, and upon
return they are reconciled and submitted to packaging.
5. Packaging: Upon
completion of processing, the product is inspected by QC for appearance, broken tablets,
damaged or overfilled capsules and a sample is withdrawn for testing. A product found to
contain minor defects is further inspected and a determination for corrective procedures
is made and effected before released for packaging. Products released by QC are either
bulk packaged in polyethylene lined fiber boxes, and labeled with complete product
information or bottled and labeled as per customer specifications. An expiration date,
based on appropriate testing by the customer, is also printed on the finished product.
Inspection and packaging records are maintained and samples are withdrawn to be retained
by QC for at least one year past the expiration date of the product.
6. Sampling & Inspection: All products are manufactured using Good
Manufacturing Practices and are continuously being monitored during processing to ensure
product quality and integrity. The
tablets are checked and tested on half-hour intervals for their physical properties and,
if necessary, corrective action is taken to maintain those properties. Representative
samples of 100 units are collected for both the core and the finished product for Quality
Control testing, customer approval and as Reference Samples, a set for each need.
7. Storage of Finished Goods: The product shall be quarantined and stored under
controlled temperature conditions until approval and shipping to the customer.
QUALITY
CONTROL PROCEDURES
 
 
Specifications,
standards, and testing and operating procedures are drafted by the respective departments
and approved by the Quality Control unit. Laboratory controls include the establishment of
specifications for raw materials, components and finished products, and testing procedures
to assure product identity, quality, strength and purity. The QC group also maintains
calibration records of all instruments at suitable intervals and in addition checks
conformance of all operations to the set procedures. In-process testing is performed by
the QC chemists to determine whether the product being manufactured conforms to
specifications. The Quality Control Unit also retains samples of raw materials (for one
year past the expiration date of the last product they are used in) arid finished products
(for one year past the product expiration date) are maintained under control conditions.
Contacting Sales
Advanced Diets Wholesale / Trade Dept
115 Chart Road
Folkestone
Kent CT19 4EP
Phone From UK 07986 154 057
Outside the UK Phone: 011 44 7986 154 057
Email:Sales
Manufacturing Plant
Advanced Diets
Century Park East
Los Angeles, CA 90067
Email: New Formulas & Private
Label
Below is a scan of the Hoodia souce certificate
Opening Hours: 9 - 5 Monday - Friday / Saturday 9 - 1pm
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2004-2005, All Rights Reserved |
