 |
|
 |
|
|
|
|
|
Quality Control |
When you choose Dietceutical Supplements for your turn key private
labeling needs you can rest assure the facilities where your products
are manufactured provide the highest quality nutritional and dietary
supplements available. Applying state-of-the-art research and technology
to help you develop and market innovative products that meet or exceed
the demanding needs of today's consumer, including custom formulations
and special requests. |
| |
At
Dietceutical Supplements, you can be sure only the highest quality
ingredients are being used in the manufacturing process. We know when
you are selling dietary supplements it is important to know what is
inside especially when you are creating custom formulas or private
labeling and putting your company branded name or Trademark on the
products label. |
| |
The
following overview below reflects some of the quality control measures
that take place in the facilities our products are produced. |
| |
|
|
|
| Organization and Personnel |
The company is structured so as to provide all necessary measures and
controls for the manufacture of products of the highest quality, which
meet safety requirements and possess the identity and strength that they
are intended to possess. An adequate number of qualified personnel is
assigned to perform and supervise the manufacture of nutritional
products, and employees are trained according to current good
manufacturing practices in the operation they are to perform. Standard
Operating Procedures (SOPs) are strictly followed in each step of the
operation.
A quality control unit has been established which
consists of the President, the Director of Quality Assurance and the
Quality Control Manager. This group is responsible for the approval or
rejection of all components used in the manufacture of a product, review
of production records and approval or rejection of finished products.
The quality control unit is also responsible for approval of procedures
and specifications that affect the production and quality of nutritional
products.
A quality control laboratory is available which is
fully equipped for testing of raw materials and finished products
according to set specifications. Retain samples of raw materials and
finished products are maintained in this laboratory for pre-established
periods of time. |
| |
| 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:
a. Receiving and quarantine area
b. Warehouse for storage of raw materials and other components
c. Pharmacy and blending
d. Staging area for storage of in-process materials
e. Production area for encapsulation
f. Production area for tableting
g. Coating area
h. Packaging and labeling area
i. Area for storage of finished products
j. Quality control laboratory
Adequate lighting and ventilation is provided
throughout 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 systems using negative air pressure for the
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, setup 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. |
| |
| 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 claims and the purchasing
department. An inventory card is generated for each lot of material
which is used by pharmacy to maintain a log of material use. Samples are
withdrawn and submitted to Quality Control for testing according to
specifications and Standard Operating Procedures (SOP's)
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 product labeling operation under strict controls. Inventory
cards 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 the 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. 055 for May
1995), 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 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. Representatives retain
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 Pharmacy. All manufacturing
records are filed according to product number and lot number, and
maintained by the Directory 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 mixups, 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 logbook is maintained for all batches
prepared by Pharmacy. Each material weighted out is subtracted from the
raw material inventory card. 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 logbook 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
retain 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 specification, the product is entered in
the machine logbook 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 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 line drums and upon
completion the batch is reconciled. Subsequently the capsules are
deducted and sent to packaging. If a product does not meet
specification, it may be reworked as per set procedures, and batch
records are updated to indicate all adjustments made to the formula and
product specification.
4. Coating: Tablets are coated soon
after completion of the batch and tablets are collected in polyethylene
line boxes. Each batch is reconciled and entered in the coating logbook
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 all
processing, the product is inspected by Quality Control 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 before being released for packaging. Products released by
Quality Control are either bulk packaged in polyethylene lined fiber
boxes, and labeled with complete product information, or bottled and
labeled as per customer specification. 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 Quality Control for at least one year past
the expiration date of the product.
6. Sampling and 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 the operating procedures are drafted by the
respective department 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 Quality
Control 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 Quality
Control 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) and finished products (for one year past
the product expiration date) are maintained under control conditions. |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
 |
|
 |
|
|
|
