This document provides an overview of Beyond A Century, Inc.'s (BAC) current good manufacturing practices (GMP) program for packaging, labeling, and holding dietary supplements. It describes BAC's personnel requirements and training, facility design and maintenance, production and process controls, quality control testing, and Hazard Analysis and Critical Control Point (HACCP) plan. The HACCP plan identifies potential biological, chemical, and physical hazards at critical control points during receiving, sampling, storage, production, and shipping. It establishes monitoring, corrective actions, verification, and documentation procedures to control these hazards and prevent product adulteration.

1. BAC Good Manufacturing Practices
in Packing, Labeling and Holding of Dietary Supplements
Revised June 2008
Below is an overview of Beyond A Century, Inc.'s current good manufacturing practices program. Our
current program, although close to meeting all requirements of Food and Drug Administration 21 CFR
Part 111, is evolving to meet these new federal regulations at the phase in deadline of August 2010. All
sections of this overview have a corresponding written procedure; SOP; and/or forms for actual
implementation. Full GMP information, procedures, sops and forms can be found in our expanded
manual. This overview serves as a general guideline to the practices and procedures we use in our
operations to insure the integrity and quality of our repackaged products. In addition, BAC uses a
HACCP model to control and monitor critical aspects of our packaging, labeling, and holding of
dietary supplements. Our HACCP model is attached.
I. Personnel
A. Disease Control
i. Any person who has, by medical examination or supervisory observation, an illness or medical
condition such as open lesions or infected wounds that could be a possible source of microbial
contamination shall be removed from the rebottling process so as to prevent adulteration of the
dietary product during packaging and storage. Personnel shall be instructed to report such health
conditions to management.
B. Cleanliness
i. All personnel having direct contact with exposed products, and packaging components, as well
as those individuals utilizing processing equipment and utensils, shall conform to a level of
basic hygiene and personal cleanliness to protect the product against adulteration. These
methods include:
a) Use of lab coats and and/or outer garments that protect against adulteration of product and
equipment.
b) Maintaining personal cleanliness
c) Washing hands thoroughly before starting work and at any other time when the hands may
have become soiled or contaminated.
d) Removing all jewelry.
e) Using gloves specifically designed for laboratory work.
f) Wearing hair nets, caps, beard covers, arm covers and other effective hair restraints.
g) Storing clothing or other personal items outside of processing area.
h) Excluding the consumption of food and drink as well as the use of chewing gum and
tobacco products.
C. Education and Training
i. All BAC laboratory personnel have written job descriptions and have training and experience to
perform their function. All personnel have received GMP and HACCP education and training.
Training is ongoing either as needed or at least quarterly.
D. Supervision
i. The responsibility for assuring compliance by all personnel to these requirements is assigned

2. first to the quality control management unit and then as a team effort by all production staff.
Adequate and proper training, education and experience for all individuals is provided on all
pertinent GMP requirements.
II. Plants and Grounds
A. Grounds
i. Grounds surrounding BAC and its rebottling plant are kept in good condition that will protect
against adulteration of product. These methods include:
a) Properly storing equipment and removing litter, refuse and vegetation within the immediate
vicinity of the buildings that could attract and harbor pests.
b) Maintaining grounds properly that could contribute to product adulteration or infestations of
pests.
c) Disposing of all waste and rubbish in a timely and proper manner to prevent adulteration of
products during rebottling and storage, and to ensure a clean, safe workplace.
B. Plant Construction and Design
i. Plant buildings and structures at BAC are of a sufficient size and construction/design to facilitate
maintenance, cleaning and sanitary operation and to prevent mix ups between different
supplements and products. This includes:
a) Sufficient space for placement or equipment and storage and spacial segregation of
materials.
b) Operating practices that reduce potential for mix-ups and adulteration of in-process or
finished product.
c) Maintenance including cleaning, sanitation, waste disposal and elimination and prevention
of pest infestations.
d) Adequate lighting in production areas.
e) Safety-type light fixtures, fitted with sleeves as necessary to protect against adulteration by
glass.
f) Ventilation and air conditioning when necessary to prevent adulteration of product and
provide a safe and clean operating environment.
g) Screening where necessary to protect again pests.
III. Sanitation of Buildings and Facilities
A. General Maintenance
i. All buildings at BAC are constructed in such a way that all equipment and work and storage
surfaces can be cleaned and sanitized. They are maintained in good repair and cleaned and
sanitized on a regularly scheduled basis.
B. Cleaning and Sanitizing Agents
i. Cleaning and sanitizing agents and pesticides, etc., are used in a safe and effective manner and
are appropriate for their intended use. They are stored in such a way that prevents the
adulteration or contamination of bulk and rebottled products.
C. Pest Control
i. Appropriate measures are taken to prevent infestations of pests.
D. Water Supply
i. BAC water supply is from a drilled well which is tested yearly for potability. The water is tested
to be appropriate for all laboratory and processing procedures.
E. Plumbing is designed, installed and maintained to:
i. Carry sufficient quantities of water throughout the plant
ii. Properly convey sewage and liquid waste from the plant.
iii. Avoid adulteration and contamination of product and equipment and plant.
iv. Prevent the contamination of fresh water.
F. Sewage Disposal
i. BAC's sewage disposal system is the public town sewer system.
G. Toilet Facilities
i. BAC's plant provides its employees with readily accessible and maintained toilet facilities which
are in good repair and sanitized at least daily. Self-closing doors are installed on these facilities

3. to protect from airborne contamination.
H. Hand-washing facilities
i. Hand-washing facilities are convenient and have fresh running water and include effective hand-
cleaning and sanitizing products; sanitary disposable towels; directions on effective hand
washing and anti-recontamination procedures.
I. Rubbish Disposal
i. Refuse containers and rubbish disposal practices protect against product adulteration and the
harbor of pests.
IV.Equipment and Utensils
A. Design and Construction
i. Equipment is installed and maintained so as to facilitate the cleaning of the equipment and
surrounding area.
ii. Equipment and utensils that come into contact with bulk product are constructed appropriately
for this use and are maintained to prevent adulteration and contamination of bulk product, in-
process and finished product by contaminants.
iii. Cleaners and sanitizers used on utensils and equipment are suitable for food processing.
iv. All freezers and refrigerators are fitted with temperature gages and are monitored continually.
B. Sanitation of Equipment and Utensils
i. All equipment and utensils are cleaned as frequently as necessary using appropriate cleaning and
sanitizing agents and stored in covered containers.
ii. Cleaning logs are maintained and reviewed on a regular basis.
V. Quality Control and Laboratory Operations
A. Quality Control Operations
i. Quality control operations are employed to assure dietary supplements conform to specifications
of purity, quality and composition and that packaging materials are safe for their intended
purpose.
a) BAC relies on established suppliers who supply certificates of analysis with all products.
b) We require our suppliers to set specifications and test or confirm testing of products for
compliance to specified identity, purity, strength, composition.
c) BAC certifies suppliers through an in-house certification program.
• Because BAC packages and labels dietary supplements that arrive in their final form in
bulk, we rely on information received from the supplier/manufacturer. We continually
assess the reliability and quality of these suppliers to assure product quality.
d) BAC employs identity examinations on incoming lots of bulk products to assure they are
consistent with the COA and purchase order.
e) Upon receiving, items are examined and compared to their certificate of analysis and
historical samples and an positive identification is made. Identity specifications, purity,
quality and composition are documented in the supplier's certificate of analysis.
f) BAC's GMP program is directed toward process controls and rigorous examinations
throughout the bottling and labeling process to preserve the integrity, purity, quality and
composition of supplements.
g) BAC periodically sends rebottled products for independent purity testing as a means of
testing our process controls and verifying our suppliers' quality.
B. Quality Control Unit
i. A quality control unit consisting of management and production staff has the responsibility of:
a) approving or rejecting all procedures, specifications, test methods and results that impact
the purity, quality and composition of an ingredient or product.
b) Approving or rejecting all components, packaging materials, labeling and finished products
including any contract-manufactured products.
c) Assuring that completed production records are reviewed and product is approved for
distribution.
d) Establishing procedures for changing and revising all documentation
e) Reviewing and approving changes to documentation

4. f) Assuring the most current revision of all documentation is in use at all times.
C. In house and/or Contract Laboratories
i. In-house and contract manufacturers must conform to all FDA & BAC GMP standards.
D. Examination Methods
i. Consistent with FDA cGMP regulations, BAC performs identity examinations on 100% of
incoming batches of bulk products to insure that the product received is consistent with our
purchase orders and COAs.
ii. Finished products are examined to insure that the finished products meet all specifications.
E. Laboratory Records
i. All records from product examinations are maintained with samples and in a separate test log.
F. Shelf Life
i. All products bear a shelf life and expiration date based on accompanying certificate of analysis.
Re-certifications are requested from bulk product suppliers if needed.
VI. Production and Process Controls
A. Master Production and Control Records
i. Master production and control records are maintained either on computer or on paper or in
combination detailing a complete list of bulk products and their suppliers, amounts of bulk
products in each finished product, packaging components, labeling information detailing the
amount and potency of each bulk product in each unit, statements of theoretical weight and its
relation to actual yield and the acceptable range beyond which investigations are initiated. Most
information is integrated into the MBPR batch record.
B. Batch and Control Records
i. A master batch record is used for each batch of rebottled product which includes:
a) dates and times
b) Specific identity, including lot number, of each supplement used.
c) Weight or measure of each bulk product
d) quality control of each step of the packaging process.
e) Statements of theoretical and actual yield
f) packaging components used.
g) Labeling information and sample of label
h) Identification of production staff involved
i) Statements of deviations and resolutions, if applicable
C. Handing and Storage of bulk products, In process materials and re-work
i. Material rework is generally only performed if the items have been stored with BAC
continuously (we generally do not receive material back and reprocess it – it is restocked if
package integrity is evident and otherwise destroyed).
ii. Reworks generally occur only under the following circumstances:
a) A packaging mistake has been made in regards to container size. In this case the product is
repackaged under a contiguous process of re bottling.
b) Packaging containers are reused after being sanitized.
D. Packaging Operations
i. All inspection, packaging and storage of BAC products are conducted in accordance with
sanitation principles in a manner that protects against adulteration and contamination.
ii. BAC bulk products, packaging materials, in process materials and finished products are
effectively spatially and otherwise segregated.
iii. Because BAC repackaging is done without the use of automated machinery, care is taken for
production workers to visually inspect in-process materials to protect against the inclusion of
extraneous materials in the product.
iv. Adulterated or defective material is quarantined and disposed of in a timely fashion.
v. All steps of the packaging and labeling process from receiving through sampling, production,
labeling and stocking of shelves is documented by written procedures.
E. Packaging and Labeling Operations

5. i. Packing and labeling of products at BAC is performed to prevent adulteration and misbranding.
ii. Labels for each product are not retained in hard copy form. Extra labels are destroyed after each
batch run to prevent misbranding. This is documented on the master batch record.
iii. All labels are checked and rechecked for accuracy and inclusion of correct lot number for batch
identification.
VII. Warehousing, Distribution and Post-Distribution Procedures
A. Storage and Distribution
i. Storage of all finished product at BAC is done under conditions that protect the product from
physical, chemical and biological adulteration as well as package product integrity.
ii. Distribution records are maintained as part of the BAC retail database and program and extend
back at least 1 year beyond the expiration or shelf life of the products.
B. Reserve Samples
i. Reserve samples are taken for BAC bulk products and retained at least one year past the
expiration date of the product. BAC samples are attached to the manufacturer's certificate of
analysis in a zip lock bag and stored in a suitable environment. Samples are in sufficient
quantity to perform necessary examinations and other testing if required. Samples of
finished/labeled products are also kept and attached to the master batch sheet.
C. Records Retention
i. All records pertaining to the receiving, holding, repackaging, and distribution of dietary
supplements are retained for at least one year past the expiration date of the product.
D. Written Recall Procedures
i. Written recall procedures for BAC labeled products are included in our GMPs and call for a
specific set of protocols to identify and contact customers, batches implicated and notification to
the FDA.
E. Complaint Files
i. Customer Complaint Records are maintained in physical hard copy form using a pre-printed
customer complaint record (which includes all pertinent customer and product information) and
also in a computer database. These records are permanently retained in computer form and
physically retained at least one year after the expiration date of the product involved.
F. Returned Products
i. Returned products are spatially segregated and inspected before either destroying or restocking.
Opened product is never reworked or restocked.
G. Product Salvaging
i. Products held by BAC that have been subjected to improper storage conditions are destroyed.

6. Beyond A Century, Inc.
173 Lily Bay Road
Greenville, ME 04441
Rev. June 2008
HACCP Plan for Receiving, Sampling, Holding, Repackaging and Shipment of
Bulk Nutritional Supplements.
Beyond A Century, Inc., along with a rigorous GMP program, utilizes a safety system known as
Hazard Analysis and Critical Control Point (HACCP) to guide and monitor its packaging and labeling
processes. By adopting HACCP, the occurrence of food-borne hazards is reduced; resulting in
improved public health protection, increased consumer confidence and overall business success.
The concept of HACCP is based upon seven basic principles.
1. Analysis of workplace hazards
2. Identification of Critical Control Points
3. Establishment of Critical Limits
4. Monitoring of Critical Control Points
5. Application of Corrective Actions
6. Verification Procedures
7. Documentation of the System
Beyond A Century, Inc. repackages over 200 bulk nutritional supplements. These
supplements are repackaged into 20 to 1,000 gram sizes. The bulk materials and
repackaged bottles are intended to be stored at room temperature, average humidity. The
repackaged items are prepared for sale/use using a detailed set of Good Manufacturing
Practices (GMPs) as documented in Beyond A Century, Inc.’s GMP manual.
ALL PROCEDURES ARE AIMED AT PREVENTING MISBRANDING;
ADULTERATION AND CROSS CONTAMINATION!
Part I:Analysis and Identification of Potential Hazards
Part II: Identification of Critical Control Points (CCP)

7. Part III: Monitoring of CCPs
Part IV: Corrective Actions for CCP Failure
Part V: Verification and Monitoring of HACCP Plan
Part VI: Record Keeping and Documentation
Diagram I: Flow chart for BAC HACCP Plan

8. Analyze and Identify Potential Hazards
I Biological:
Receiving: Potential contamination from loss of package integrity
Sampling: Potential contamination from opening
Storage: Improper storage procedure
Production: Potential cross contamination/adulteration
Shipping: Improper packing/shipping procedures
II Chemical:
Receiving: Potential contamination from loss of package integrity
Sampling: Potential contamination from opening
Storage: Improper storage procedure
Production: Potential cross contamination/adulteration
Shipping: Improper packing/shipping procedures
III Physical:
Receiving: Improper unloading/moving procedure
Sampling: Potential contamination from opening
Storage: Improper moving/storing
Production: Potential cross contamination/adulteration
Shipping: Improper packing/shipping procedures

9. Identify Critical Control Points
I Receiving: Unloading and receiving procedures – see GMP SOP:
Receiving Bulk products; Form RRMS. All received products are inspected
for integrity, cleanliness of packaging. Packages are wiped down as
needed to prevent contamination from outside sources. Critical limits
established per GMPs.
II Sampling: See GMP SOP: Bulk Product Receiving and Examination
Log; Receiving Bulk product; Form RRMS. Items are examined by
management to insure that the product ordered is consistent with product
received and accompanying COA. If product is accepted, sample is taken
and product is reclosed and sent to storage. Critical limits established per
GMPs.
III Storage: See GMP SOP Pest Control; Form PEST; SOP Cleaning
Operations; Form ML; Policy: Sanitation of Buildings and Facilities. Items
are stored in warehouse storeroom which is maintained in accordance
with GMPs. Items are stored off floor level to reduce risk to acceptable
levels of contamination/adulteration. Items stored to prevent cross
contamination and product confusion. Critical limits established per
GMPs. Items that are allergens are marked with identifying tape.
IV Production: See GMP SOP: Lab Quality Control; Daily Production;
Production Area Clean-up; Form MBPR. Selecting Product; Comparing
against certificate of analysis and inspection of product; Production Run;
Capping; Labeling; Final Quality Control Check. All points are addressed
by Form: MBPR to ensure bulk product identity, purity and finished
product identity, purity, weight, labeling and overall quality. Critical limits
established per GMPs. Periodically send rebottled and labeled product to
independent laboratory for purity testing.
V Shipping: See GMP SOP: Prepacking Procedures and SOP: Order
Packing. Packing and shipping procedures designed to minimize risk to
acceptable levels of product contamination/adulteration in shipping
process. Critical limits established per GMPs.

10. Monitoring Of Critical Control Points (CCP)
I Receiving: Monitoring procedures done with each occurrence.
II Sampling: Monitoring procedures done with each occurrence.
III Storage: Continuous. Facilities inspected and maintained per GMPs
(Policy: Sanitation of Buildings and Facilities.)
IV Production: Continuous per GMPs. Additional QC verification added
to MBPR to include all production steps. Spot checks for compliance
instituted October 2006.
V Shipping: Continuous per GMPs.

11. Corrective Actions for CCP Failure
I Receiving: Established per GMPs; product is rejected and quarantined
and management notified to replace rejected product. (See GMP: Form
MRN)
II Sampling: Established per GMPs; product is rejected and quarantined
and management notified to replace rejected product. (See GMP: Form
MRN)
III Storage: Established per GMPs; facilities are inspected, cleaned and
deficiencies addressed immediately. If product is affected, product is
quarantined and referred to management for replacement/disposal.
IV Production: Established per GMPs; if product does not meet
specifications at any point in the production process, Material Rejection
Notice is completed and referred to management for
replacement/disposal/reworking.
V Shipping: Established per GMPs; if product is affected, Material
Rejection Notice is completed and referred to management for
replacement/disposal/correction. Employee brings shipping procedure to
attention of management for SOP revision (See GMP: Form SOP Revision)
Verification and Monitoring of HAACP Plan
I Routine Quarterly Review SOP/Retraining
II GMP/HAACP Cross Check Plan
Record Keeping and Documentation of HAACP Plan
I SOPs and Checklists for Review of HAACP Plan
II Corrective Action File

12. FlowDiagram
BAC HACCP Plan
Step 1: Receive Bulk Product
Accept,
Proceed to 2.
Reject
Item Quarantined; Form MRN;
Referred to management
Step 2: Sample Bulk Product;
Identify; Periodically Test for Purity
Step 3: Store Bulk Product
Step 4: Repackage Bulk Product
Step 5: Stock and Ship Finished
Product
Accept, Proceed to step 3 Reject
Item Quarantined; Form MRN;
Referred to management
Accept, Proceed to Step 4 Rejection/Storage Problem
If product affected, Item Quarantined; Form
MRN; Referred to management; Policy/SOP
revision
Accept, Proceed to Step 5 Rejection of in process material
Item Quarantined; Form MRN; Referred to
management
Policy/SOP revision/Retraining
Accept, Ship item. Process Complete
Rejection in Stocking/Shipping
Process
Form MRN; Referred to management
Policy/SOP revision/Retraining